Heart and peripheral vascular valve replacement in conjunction with a support ring

ABSTRACT

An implantable valve replacement system for a cardiovascular valve may include an adjustable stabilizing ring. The stabilizing ring may be composed of a body member that is transitionable from an elongate insertion geometry to an annular operable geometry. The stabilizing ring may further include a plurality of anchors deployable in the annular operable geometry to engage the annulus of the cardiovascular valve. The ring may be used in conjunction with an implantable valve frame. The valve frame may be located within the ring and the ring, in turn, may be stabilized through the anchors engaging the valve annulus. The valve replacement system may be applied by engaging the ring in its annular operable geometry with the valve annulus through the anchors. The valve frame may be inserted through the opening of the ring, thereby forming a stabilizing mechanical contact between the frame and the annulus.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation application of U.S. Pat. ApplicationNo. 15/336,310, filed Oct. 27, 2016, and entitled “HEART AND PERIPHERALVASCULAR VALVE REPLACEMENT IN CONJUNCTION WITH A SUPPORT RING,” which isa continuation of U.S. Pat. Application Serial No. 14/893,131, filedNov. 23, 2015, and entitled “HEART AND PERIPHERAL VASCULAR VALVEREPLACEMENT IN CONJUNCTION WITH A SUPPORT RING,” which is a U.S.National Stage filing under 35 U.S.C. § 371 of International ApplicationNo. PCT/US2014/039454 filed on May 23, 2014 that claims the benefit ofand priority to U.S. Provisional Pat. Application No. 61/827,531,entitled “HEART AND PERIPHERAL VASCULAR VALVE REPLACEMENT IN CONJUNCTIONWITH A SUPPORT RING,” filed May 24, 2013, the disclosures of which arehereby incorporated herein by reference in their entireties.

BACKGROUND

There are four valves in the heart that serve to direct blood flowthrough the two sides of the heart. On the left (systemic) side of theheart are the mitral valve, located between the left atrium and the leftventricle, and the aortic valve, located between the left ventricle andthe aorta. These two valves may direct oxygenated blood from the lungsthrough the left side of the heart and into the aorta for distributionto the body. On the right (pulmonary) side of the heart are thetricuspid valve, located between the right atrium and the rightventricle, and the pulmonary valve, located between the right ventricleand the pulmonary artery. These two valves may direct de-oxygenatedblood from the body through the right side of the heart and into thepulmonary artery for distribution to the lungs, where the blood becomesre-oxygenated. The cardiac valves are composed of moveable features,generally described as leaflets or cusps. The mitral valve has twoleaflets, and the tricuspid valve has three leaflets. The aortic andpulmonary heart valves have leaflets that are shaped somewhat likehalf-moons and are typically described as cusps. Each of the aorticvalve and the pulmonary valve has three cusps.

Other valves, such as venous valves, may be present in the vascularsystem to aid in directing the flow of blood through the body. Suchperipheral vascular values typically have a single leaflet structure andact as gates to prevent blood from flowing backward. For example, as aleg muscle contracts, the venous vessels may be compressed, and theblood may be pushed through a valve. As the muscle relaxes, the bloodmay be prevented from flowing backwards as the valve closes. The one-wayvenous valves may ensure that the blood flows in one direction backtowards the heart.

All heart and vascular valves are passive structures that simply openand close in response to differential pressures on either side of thevalve. They do not, in general, expend energy and do not perform anyactive contractile function. The cardiovascular valves may exhibitabnormal anatomy and function as a result of congenital or acquiredvalve disease. Congenital valve abnormalities may be well-tolerated formany years only to develop a life-threatening problem in an elderlypatient. Alternatively, such abnormalities may be so severe thatemergency surgery may be required in-utero or within the first few hoursof life. Acquired valve disease may result from such causes as rheumaticfever, degenerative disorders of the valve tissue, bacterial or fungalinfections, and trauma.

Since the cardiovascular valves are passive structures, valve failuremodes can be classified into two categories: stenosis, in which a valvedoes not open properly; and insufficiency (also called regurgitation),in which a valve does not close properly. Stenosis and insufficiency mayoccur at the same time in the same valve or in different valves. Both ofthese abnormalities may increase the workload placed on the heart aswell as other organs of the body, such as the liver and kidneys. Inparticular, the severity of this increased stress on the heart, and theheart’s ability to adapt to it, may determine whether an abnormal valvecan be repaired or if valve removal and/or replacement is warranted.

SUMMARY

In an embodiment, an implantable valve system may include an adjustablestabilizing ring having a body member that is transitionable from anelongate insertion geometry to an annular operable geometry, and aplurality of anchors deployable in the annular operable geometry toengage the annulus of the cardiovascular valve. The elongate insertiongeometry of the body member may be configured to allow percutaneouspassage of the stabilizing ring, via a catheter, to a position adjacentto an annulus of a cardiovascular valve. The annular operable geometryof the body member may have a closed state to conform to the annulus ofthe cardiovascular valve. The implantable valve system may furtherinclude an implantable valve frame in mechanical communication with theadjustable stabilizing ring.

In an embodiment, a platform to stabilize an implantable valve frame mayinclude an adjustable stabilizing ring having a body member that istransitionable from an elongate insertion geometry to an annularoperable geometry, and a plurality of anchors deployable in the annularoperable geometry to engage the annulus of the cardiovascular valve. Theelongate insertion geometry of the body member may be configured toallow percutaneous passage of the stabilizing ring, via a catheter, to aposition adjacent to an annulus of a cardiovascular valve. The annularoperable geometry of the body member may have a closed state to conformto the annulus of the cardiovascular valve. The adjustable stabilizingring in the closed state of the annular operable geometry may beconfigured to receive and stabilize the implantable valve frame at aposition proximal to the annulus of the cardiovascular valve.

In an embodiment, a method of stabilizing a replacement of acardiovascular valve may include inserting a distal end of a cathetercomprising a delivery system into a cardiovascular valve, guiding, viathe delivery system, an adjustable stabilizing ring in an elongategeometry from a proximal end of the catheter to the distal end of thecatheter such that the adjustable stabilizing ring transitions to anannular operable geometry upon exiting the distal end of the catheter,deploying a number of anchors from the adjustable stabilizing ring toengage an annulus of the cardiovascular valve, guiding an implantablevalve frame including the replacement of the cardiovascular valvethrough the cardiovascular valve and through a center of the adjustablestabilizing ring, and engaging at least a portion of the implantablevalve frame with the adjustable stabilizing ring, thereby stabilizing aposition of the implantable valve frame with respect to thecardiovascular valve.

In an embodiment, a method of replacing a cardiovascular valve mayinclude inserting a distal end of a catheter comprising at least onedelivery system into a cardiovascular valve, guiding, via the at leastone delivery system, an implantable valve frame having the replacementof the cardiovascular valve through the cardiovascular valve, expandingthe implantable valve frame, guiding, via the at least one deliverysystem, an adjustable stabilizing ring in an elongate geometry throughthe implantable valve frame and the replacement of the cardiovascularvalve such that the adjustable stabilizing ring transitions to anannular operable geometry around an exterior of the implantable valveframe upon exiting the distal end of the catheter, engaging at least aportion of the implantable valve frame with the adjustable stabilizingring, and deploying a number of anchors from the adjustable stabilizingring to engage an annulus of the cardiovascular valve.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A depicts a perspective view of an illustrative adjustableannuloplasty ring in an annular (D-shaped) operable geometry and acontracted state according to an embodiment.

FIG. 1B depicts a perspective view of an illustrative adjustableannuloplasty ring in an expanded state according to an embodiment.

FIG. 1C depicts a schematic diagram of an illustrative cutting patternused for laser processing a hypotube of an adjustable annuloplasty ringaccording to an embodiment.

FIG. 2A depicts a schematic diagram of a perspective view of a secondillustrative adjustable annuloplasty ring in an annular (D-shaped)operable geometry and a contracted state according to an embodiment.

FIG. 2B depicts a schematic diagram of a perspective view of anillustrative adjustable annuloplasty ring in an expanded state accordingto an embodiment.

FIG. 3A depicts a schematic diagram of a perspective view of a secondillustrative adjustable annuloplasty ring in an annular (D-shaped)operable geometry and in an expanded state according to an embodiment.

FIG. 3B depicts a schematic diagram of a perspective view of a secondillustrative adjustable annuloplasty ring in a contracted stateaccording to an embodiment.

FIGS. 4A and 4B depict a perspective view and a cross-sectional view,respectively, of an illustrative stepped connector of an adjustableannuloplasty ring according to an embodiment.

FIG. 5A depicts a schematic diagram illustrating a side view of aninternal anchor ribbon including a plurality of curved anchors accordingto an embodiment.

FIG. 5B depicts a schematic diagram of a top view of illustrativeanchors cut into an internal anchor ribbon in an elongate insertiongeometry according to an embodiment.

FIG. 5C depicts a schematic diagram of a side view of an illustrativeinternal anchor ribbon in an elongate insertion geometry and a pluralityof anchors in a curled or curved deployed configuration according to anembodiment.

FIG. 5D depicts a schematic diagram of a top view of an illustrativeinternal glide ribbon in an elongate insertion geometry according to anembodiment.

FIG. 5E depicts a schematic diagram of a side view of an illustrativeinternal glide ribbon according to an embodiment.

FIGS. 5F and 5G depict a front view and a side view, respectively, of atube-like polymeric element according to an embodiment.

FIGS. 5H, 5I, and 5J depict a top view, a first side view, and a secondside view, respectively, of a polymeric element according to anembodiment.

FIGS. 6A and 6B depict schematic diagrams of cross-sectional side viewsof an annuloplasty ring before (FIG. 6A) and after (FIG. 6B) deploymentof a plurality of anchors according to an embodiment.

FIG. 6C depicts a schematic diagram of a side view of various segmentsof illustrative internal anchors according to an embodiment.

FIG. 7 depicts a schematic diagram of a side view of an illustrativeinternal anchor member including linear anchors according to anembodiment.

FIG. 8A depicts a schematic diagram of an illustrative trans-septalapproach for endovascular delivery of an annuloplasty ring to the mitralvalve of a heart according to an embodiment.

FIG. 8B depicts a schematic diagram of an illustrative retrogradeapproach of an annuloplasty ring to the mitral valve of a heartaccording to an embodiment.

FIG. 8C depicts a schematic diagram of an illustrative trans-apicalapproach of an annuloplasty ring to the mitral valve of a heartaccording to an embodiment.

FIG. 9A depicts a flow diagram of a first illustrative method of placingan annuloplasty ring at a target valve according to an embodiment.

FIG. 9B depicts a flow diagram of a second illustrative method ofplacing an annuloplasty ring at a target valve according to anembodiment.

FIGS. 9C, 9D, 9E, and 9F depict schematic diagrams of transcatheterdelivery of an annuloplasty ring from a delivery system according tovarious embodiments.

FIG. 10 depicts a schematic diagram of a perspective, partialcross-sectional view of a heart during an expansion of an adjustableannuloplasty ring using a balloon expansion tool, preparatory toaffixation to the annulus of the mitral valve according to anembodiment.

FIG. 11 depicts a schematic diagram of a perspective, partialcross-sectional view of the heart during an expansion of an adjustableannuloplasty ring using a cage or basket expansion tool, preparatory toaffixation to the annulus of the mitral valve according to anembodiment.

FIGS. 12A and 12B depict perspective views of a stabilizer of apercutaneous annuloplasty system according to an embodiment.

FIGS. 12C and 12D depict a stabilizer including a balloon, according toan embodiment.

FIG. 12E depicts a schematic diagram that demonstrates how holes in thearms of a stabilizer may be used to help guide sutures that are exitingthe ring according to an embodiment.

FIGS. 13A, 13B, 13C, and 13D depict perspective views of a stabilizer ofa percutaneous annuloplasty system according to an embodiment.

FIGS. 13E-13G depict a perspective view, a side view, and a top view,respectively, of an illustrative annuloplasty ring having stratsaccording to an embodiment.

FIGS. 13H and 13I depict a top view and a detailed view, respectively,of an engagement of an annuloplasty ring having strats with a stabilizeraccording to an embodiment.

FIGS. 14A and 14B depict perspective views of a stabilizer of apercutaneous annuloplasty system according to an embodiment.

FIG. 15A depicts a perspective view of a proximal end of a handle of apercutaneous annuloplasty system according to an embodiment.

FIG. 15B depicts a cross-sectional view of the proximal end of a handleof a percutaneous annuloplasty system according to an embodiment.

FIGS. 16A and 16B depict diagrams of perspective views of anillustrative delivery system of a percutaneous annuloplasty systemaccording to an embodiment.

FIGS. 17A and 17B depict illustrative examples of a full assembly of thering, stabilizer and distal end of the catheter as configured in atarget site after deployment of the ring from the catheter according toan embodiment.

FIGS. 18A and 18B depict illustrative longitudinal cross-sectional viewsof a catheter connecting the distal end of the delivery system of FIG.17A to the proximal end of the delivery system of FIGS. 16A or 16Baccording to an embodiment.

FIGS. 19A, 19B, and 19C depict illustrative examples of the proximalside of a delivery system which functions as a handle according to anembodiment.

FIG. 20A depicts a perspective view of an illustrative example of anadjustable valve support ring in an extended state according to anembodiment.

FIG. 20B depicts a perspective view of an illustrative example of anadjustable valve support ring in a closed geometry according to anembodiment.

FIG. 20C depicts a perspective view of an illustrative example of anadjustable valve support ring in a closed geometry with extended anchorsaccording to an embodiment.

FIG. 21A depicts an isometric view of an illustrative example of anangled D-shaped cylindrical valve frame according to an embodiment.

FIG. 21B depicts an isometric view of an illustrative example of anangled cylindrical valve frame according to an embodiment.

FIG. 21C depicts a side view of the D-shaped valve frame depicted inFIG. 21A or the cylindrical valve frame depicted in FIG. 21B accordingto an embodiment.

FIG. 21D depicts an isometric view of an illustrative example of astraight D-shaped valve frame according to an embodiment.

FIG. 21E depicts a side view of the straight D-shaped valve framedepicted in FIG. 21D according to an embodiment.

FIG. 21F depicts an isometric view of an illustrative example of astraight cylindrical valve frame further depicting support elements anda continuous bridging element surface according to an embodiment.

FIG. 21G depicts an isometric view of an illustrative example of astraight cylindrical valve frame further depicting support elements anda plurality of independent bridging elements according to an embodiment.

FIG. 21H depicts an illustrative example of an adjustable stabilizingring according to an embodiment.

FIG. 22A depicts a top view of an illustrative example of an angledD-shaped cylindrical valve frame including an exemplary bi-leaflet valveaccording to an embodiment.

FIG. 22B depicts a top view of an illustrative example of an angledcylindrical valve frame including an exemplary tri-leaflet valveaccording to an embodiment.

FIG. 22C depicts a top view of an illustrative example of a straightD-shaped cylindrical valve frame including an exemplary bi-leaflet valveaccording to an embodiment.

FIG. 23A depicts a perspective view of an illustrative example of animplantable valve system including an adjustable valve support ring in aclosed geometry with extended anchors and an angled D-shaped cylindricalvalve frame including an exemplary bi-leaflet valve according to anembodiment.

FIG. 23B depicts a top view of the implantable valve system depicted inFIG. 23A.

FIG. 23C depicts a perspective view of an illustrative example of animplantable valve system including an adjustable valve support ring in aclosed geometry with extended anchors and an angled cylindrical valveframe including an exemplary tri-leaflet valve according to anembodiment.

FIG. 23D depicts a top view of the implantable valve system depicted inFIG. 23C.

FIG. 24A depicts an isometric view of an illustrative example of anangled D-shaped cylindrical valve frame having attachment anchors for asupport ring according to an embodiment.

FIG. 24B depicts an isometric view of an illustrative example of animplantable valve system including an adjustable valve support ring in aclosed geometry with extended anchors secured to an angled D-shapedcylindrical valve frame having attachment anchors according to anembodiment.

FIG. 25 depicts a flow diagram of an illustrative method of stabilizinga replacement cardiovascular valve according to an embodiment.

FIG. 26 depicts a flow diagram of an illustrative method of replacing acardiovascular valve according to an embodiment.

DETAILED DESCRIPTION

The valve structures in the heart and vascular system are not composedof rigid tissues but have some natural compliance. The naturalcompliance of a valve may aid in its natural functional performance.However, if the valve is diseased, the compliance may changesignificantly, and the function of the valve may be compromised. If thenatural tissue structure surrounding the valve is weak, supplementalsupport of the surrounding tissue may be highly desirable. If the valvestructure is not badly compromised, the supplemental support alone maybe sufficient to restore the valve’s normal function. However,supplemental support alone may not be sufficient to restore a valve’snormal function, and the diseased valve may require replacement with aprosthesis.

Minimally invasive or percutaneous valve replacement surgery or valvefunction replacement is well known in the art and a number of surgicaloptions are available. However, the currently available valvereplacement procedures may be difficult to employ for valve implantationin some areas of the heart (e.g. mitral valve, tricuspid valve) or inperipheral (e.g. venous) vasculature where the tissue is naturallyhighly compliant or highly compliant due to disease. While the rigidframes used to support the flexible leaflets in replacement valves maybe able to hold the replacement prosthetic valve in position acutely, itis difficult for them to remain in place over a long period of time dueto the dynamic and compliant nature of the surrounding tissue.Therefore, there is a need for an improvement to allow the prostheticvalve to be implanted within these more highly compliant structures.Through the use of a separate minimally or percutaneously deliveredsupport ring, which may be delivered and secured to the surroundingtissue or annulus thereby reinforcing it, a replacement prosthetic valvecould then be implanted within the support ring and remain in positionto provide the long-term benefit it is designed for.

A rigid or semi-rigid support ring may be delivered to the valve areavia small bore delivery systems or catheters using percutaneous methods.Such a support ring may be external to the replacement valve and couldprovide the support needed for the replacement prosthetic valve. The useof such a support ring may allow the replacement valve to remainpermanently or semi-permanently in place.

A support ring that can be used in conjunction with a prosthetic valvemay be fabricated from a biocompatible, durable, non-thrombogenic,sterilizable, material and may further exhibit advantageous hemodynamicperformance. As cardiovascular procedures become minimally invasive, asupport ring or structure that can be delivered using percutaneousprocedures and secured to allow for secondary implantation of aprosthetic valve is needed.

The following terms shall have, for the purposes of this application,the respective meanings set forth below.

A “heart valve” refers to any valve of a heart. In some embodiments, theheart may be a human heart. In other embodiments, the valve may be anon-human heart. The heart valves include atrioventricular valves(mitral valve and tricuspid valve) and semilunar valves (aortic valveand pulmonary valve). As used herein, the term “valve” is used to denotea heart valve, except where explicitly stated otherwise. Variousportions of the heart, including the valves, may contain one or morefibrous rings therearound. Such a fibrous ring is commonly known (andused herein) as an “annulus.”

A “patient” refers to any human or non-human individual. The patient isgenerally any patient that has been diagnosed or will be diagnosed witha valve-related disorder, such as, for example, a heart valve-relateddisorder. In some embodiments, the patient may be an individual thatwould benefit from the apparatuses, systems, and methods describedherein.

As used herein, “percutaneous” refers to a procedure that uses incisionsthrough the skin of the abdomen for access to a surgical site, such as,for example, a patient’s heart. Thus, as used herein, percutaneoussurgery and laparoscopic surgery are mutually exclusive. In thepreferred embodiment, the methods described herein are performedpercutaneously, although laparoscopic methods are contemplated. As usedherein, a percutaneous procedure may be a minimally invasive procedureor a highly invasive procedure. A percutaneous procedure may alsoinclude a trans-septal approach, a trans-apical approach, or a transatrial approach.

The systems and methods described herein may generally be used tofacilitate repair of a heart valve through percutaneous trans-catheterdelivery and fixation of an annuloplasty ring to the heart valve. Theembodiments of stabilizers and delivery systems can be configured inelongated insertion geometries that can be inserted into a catheter tubeand deployed to an operable geometry providing a 3D geometry thatcorresponds to and attaches to an annuloplasty ring connected to acatheter delivery system.

FIG. 1A depicts a schematic diagram of a perspective view of anillustrative adjustable annuloplasty ring, generally designated 100,according to an embodiment. As shown in FIG. 1A, the annuloplasty ring100 may be in an annular (D-shaped) operable geometry in a contractedstate. FIG. 1B depicts a schematic diagram of a perspective view of theadjustable annuloplasty ring 100 of FIG. 1A when in an expanded state.The annuloplasty ring 100 may be configured to enable percutaneous,transcatheter annuloplasty to repair a heart valve. The annuloplastyring 100 may be fastened, percutaneously, to the annulus of a targetheart valve while in the expanded state and reduced to the contractedstate to decrease an A-P distance of the target valve and therebyimprove leaflet coaptation of the target valve and reduce regurgitationthrough the target valve.

Referring collectively to FIGS. 1A and 1B, the annuloplasty ring 100 mayinclude a body member 101 having a plurality of regions 102 a, 102 b,102 c (collectively 102), biasing elements 103 a, 103 b (collectively103), a plurality of anchors 104, a ring closure lock 106, and a pivot108. In FIGS. 1A and 1B, as well as in other embodiments disclosedherein, the body member 101, including the plurality of regions 102, maybe arranged in a “D-shape” in the operable geometry. The D-shapedannuloplasty ring 100 may have a particular geometrical ratio that is inconformance (or approximate conformance) with the anatomical geometry ofthe human mitral valve annulus. For example, in certain embodiments, theratio of the A-P distance to the commissure-commissure (C-C) distance ofthe annuloplasty ring 100 when implanted (for example, in the contractedstate) may be about 0.55 to about 0.80, including about 0.55, about0.60, about 0.65, about 0.70, about 0.75, about 0.80, or any value orrange between any two of these values (including endpoints). In aparticular embodiment, the implanted ratio of the A-P distance to theC-C distance may be about 0.73.

Although the illustrated embodiment of an annuloplasty ring 100 of FIGS.1A and 1B is a D-shaped operable geometry, those having ordinary skillin the art will recognize that other annular-shaped operable geometriesmay also be used without departing from the present disclosure. Forexample, circular or oval operable geometries may be used.

In some embodiments, the body member 101 may include a hollow hypotube(or outer hollow member). The hypotube may be cut from, for example, atube to form the plurality of regions 102. The cuts may define a shapeand/or characteristics of the body member 101. For example, laser cutsmay define the plurality of regions 102 (and define how the plurality ofregions interact), anchor windows 110, and/or the biasing elements 103.

In various embodiments, the body member 101 may include a shape memory(such as, for example, nitinol) hypotube into which a plurality of cutsand/or segments may be laser cut to define a size, a shape, and/orcharacteristics of the plurality of regions 102. The shape memoryhypotube may be heat set to a “memorized” annular shape (such as, forexample, the D-shaped operable geometry). The shape memory hypotube maybe superelastic such that applying sufficient stress may place the bodymember 101, including the plurality of regions 102, into an elongateinsertion geometry and releasing the stress allows the body member 101,including the plurality of regions 102, to resume the D-shaped operablegeometry. In some embodiments, laser cuts may define a flexibility ofthe body member 101. For example, the laser cuts may allow the bodymember 101 to be flexible when the annuloplasty ring 100 is in anelongate insertion geometry (as described herein) and/or rigid when theannuloplasty ring is in the operable geometry.

In addition to the operable geometry shown in FIGS. 1A and 1B, the bodymember 101 may transitionable from an elongate insertion geometry (see,for example, FIG. 9C) to the annular operable geometry shown in FIGS. 1Aand 1B. The elongate insertion geometry may allow the annuloplasty ring100 to be inserted into and passed through a catheter for percutaneouspassage into the heart of a patient, as described in greater detailherein. A transition from an elongate insertion geometry to an annularoperable geometry is illustrated in FIGS. 9C-9F, and discussed hereinwith reference to the same.

Once in an annular operable geometry as shown in FIGS. 1A and 1B, theannuloplasty ring 100 may have a contracted state as shown in FIG. 1Aand an expanded state as shown in FIG. 1B. The biasing elements 103 maybe configured to expand to increase the A-P distance of the annuloplastyring 100 to an expanded state. The A-P distance AP1 of the contractedstate of FIG. 1A is enlarged by a distance d such that the A-P distanceAP2 of the expanded state FIG. 1B is larger (AP2 = AP1 + d). Expansionof the biasing elements 103 may allow the body member 101 to be expandedto an expanded state. In situ in the heart, expansion of the body member101 to the expanded state may enlarge the annuloplasty ring 100 to asize conforming, or approximately conforming, to an annulus of a targetheart valve to be repaired. Expansion of the body member 101 may beaccomplished by an expansion tool, such as a balloon, a cage, or anothertool such as is shown in FIGS. 10, 11, 12A-12E, 13A-13D, and 14A-14B,and described herein with reference to the same. In the illustratedembodiment of FIGS. 1A and 1B, a biasing element 103 a disposed betweena first posterior region 102 a and an anterior region 102 c and abiasing element 103 b disposed between a second posterior region 102 band the anterior region 102 c may enable a desired expansion from thecontracted state shown in FIG. 1A to the expanded state shown in FIG.1B.

The expanded state of FIG. 1B may be such that the annuloplasty ring 100is disposed in abutment with, or in intimate contact with, the annulusof the target valve. Disposing the annuloplasty ring 100 in intimatecontact with the annulus may enhance an anchoring process in which theplurality of anchors 104 are deployed to fasten the annuloplasty ring100 to the annulus. Once the annuloplasty ring 100 is fastened to theannulus, it may be contracted from the expanded state of FIG. 1B back tothe contracted state of FIG. 1A to reduce a diameter of the annulus ofthe target valve.

Contraction of the annuloplasty ring 100 from the expanded state to thecontracted state may decrease the A-P distance of the annuloplasty ringand, with the plurality of anchors 104 securing the annuloplasty ring tothe annulus, may also decrease an A-P distance of the target valve toimprove leaflet coaptation and reduce regurgitation through the targetvalve. In the illustrated embodiment of FIGS. 1A and 1B, contraction ofthe annuloplasty ring 100 from the expanded state to the contractedstate may be accomplished by the biasing elements 103. The biasingelements 103 may bias the annuloplasty ring 100 toward the contractedstate such that expansion of the annuloplasty ring to the expanded statestores potential energy in the biasing elements 103. Releasing thebiasing elements 103 (such as, for example, releasing or otherwiseremoving an expansion tool and/or expansion force) may release thestored potential energy, thereby forcing movement of the first posteriorregion 102 a and the second posterior region 102 b of the body member101 toward the anterior region 102 c of the body member to decrease theA-P distance of the annuloplasty ring 100 to the contracted state. Inother words, the biasing elements 103, upon release, may activelytransition the annuloplasty ring 100 from the expanded state to thecontracted state.

A typical range for change of the A-P distance d (between the expandedstate and the contracted state) may be about 3 mm to about 8 mm,including about 3 mm, about 3.5 mm, about 4 mm, about 4.5 mm, about 5mm, about 5.5 mm, about 6 mm, about 6.5 mm, about 7 mm, about 7.5 mm,about 8 mm, or any value or range between any two of these values(including endpoints). In some embodiments, the range of d may depend onthe overall size of the annuloplasty ring 100. For example, for a finalgeometry of the annuloplasty ring 100 that is 26 mm, a change distance dof about 3 mm may be desired. As another example, for a final geometryof the annuloplasty ring 100 that is 36 mm, a change distance d of about5 mm may be desired.

The biasing elements 103 of the illustrated annuloplasty ring 100 ofFIGS. 1A and 1B may be a spiral cut or helical portion of the bodymember 101 that is laser cut into the body member. The spiral cut orhelical portion, because it is cut into the body member 101, is abiasing element 103 that is integral to the body member. The spiral cutportion of the body member 101, as shown in FIG. 1B, may form orotherwise define a spiral shape configured to expand to allow theanterior region 102 c to move away from the first posterior region 102 aand from the second posterior region 102 b, thereby increasing the A-Pdistance of the annuloplasty ring 100. Also, the spiral cut or helicalportion of the body member 101 may be biased toward a relaxed position,or the contracted state as shown in FIG. 1A, such that expansion of thespiral cut or helical portion stores potential energy and release of anexpansion force results in a release of potential energy and contractiontoward the contracted state.

In some embodiments, other integral biasing elements 103 may be used.For example, a diamond cut pattern cut into the body member 101 mayallow desired expansion and biasing toward the contracted state. Inanother embodiment, a corrugated pattern (such as, for example, folds)may be formed in the body member 101. The corrugated pattern may allowdesired expansion to increase the A-P distance of the annuloplasty ring100 and may be biased toward the contracted state.

In addition to integral biasing elements 103 (formed integrally in thebody member 101 of the annuloplasty ring 100), other biasing elements103 may be used that are not integral to the body member. For example,FIGS. 2A and 2B illustrate an embodiment in which the biasing element203 is a spring and not integral to the body member 201, as describedherein. In still other embodiments, the biasing element 203 may includea nonintegral biasing component (such as, for example, a spring) tocomplement or enhance operation of an integrally formed biasing element.

Referring back to FIGS. 1A and 1B, the plurality of anchors 104, asnoted above, may be configured to secure the annuloplasty ring 100 tothe annulus of the heart valve. In some embodiments, the anchors 104 maybe barbs. As used herein, the terms “anchor” and “barb” may be usedinterchangeably. In certain embodiments, the anchors 104 are sufficientsuch that additional suturing of the annuloplasty ring 100 to the valveannulus is not needed. As shown in FIG. 1A, the anchors 104 may bewithin the body member 101 in an insertion geometry. As shown in FIG.1B, the anchors 104 may be curved in the illustrated deployedconfiguration. The anchors 104 in other embodiments may include othershapes, such as linear or helical deployed configurations. In certainembodiments, the anchors 104 may include a shape memory material (suchas, for example, nitinol) that is heat set to a deployed configuration(such as, for example, a curved configuration, a linear configuration,or a helical configuration). Those with ordinary skill in the art willrecognize that combinations of different deployed anchor configurationsmay also be used without departing from the scope of the presentdisclosure.

The anchors 104 may be superelastic such that applying sufficient stressplaces the anchors into an introduction configuration and releasing thestress allows the anchors to resume their respective deployedconfigurations. In certain embodiments, the anchors 104 may lay flatagainst the body member 101 in the introduction configuration duringinsertion of the annuloplasty ring 100 through the catheter. Asdescribed in greater detail herein, in other embodiments, the anchors104 may be retracted inside the hollow body member 101 of theannuloplasty ring 100 in the introduction configuration during insertionof the annuloplasty ring 100 through the catheter. In such embodiments,the anchors 104 may be selectively deployed at a desired time (such as,for example, after the annuloplasty ring 100 is properly positionedagainst, or in abutment with, the annulus of the heart valve). Incertain embodiments, the superelastic property of the anchors 104 may beused to self-propel the anchors into the annulus of the heart valve. Theanchors 104 may be configured to be deployed from within the body member101 through the anchor windows 110.

The ring closure lock 106 may be used to secure two open ends of theannuloplasty ring 100 to form a closed ring of the operable geometry. Incertain embodiments, the ring closure lock 106 may include a female snapand a male snap. As discussed in greater detail herein, the annuloplastyring 100 may be “snap locked” using wires or sutures to pull a male snapinto a female snap. The ring closure lock 106 of the illustratedannuloplasty ring 100 of FIGS. 1A and 1B may be disposed at a posteriorside of the annuloplasty ring. The ring closure lock 106 may allow anangled coupling of the two ends, such as, for example, at an apex of acurved side of a D-shaped annular operable geometry.

The pivot 108 may be used to automatically rotate the annuloplasty ring100 after it exits the catheter within the heart to align the plane ofthe annuloplasty ring 100 (in the annular operable geometry) with theplane of the heart valve. The annuloplasty ring 100 may be pushed fromthe catheter in a direction that is substantially perpendicular to theplane of the heart valve (such as, for example, parallel to the generaldirection of blood flow through the valve). Upon exiting the catheter,the annuloplasty ring 100 may be rotated at or about the pivot 108 toallow proper positioning of the annuloplasty ring 100 against theannulus. With the annuloplasty ring 100 properly oriented in alignmentwith the plane of the heart valve, the annuloplasty ring 100 may beexpanded to the expanded state. For example, an expansion tool may be beused to expand the annuloplasty ring 100, as shown in FIGS. 10, 11,12A-12E, 13A-13D, and 14A-14B and described in greater detail herein.The annuloplasty ring 100 in the expanded state may be pressed againstthe valve annulus before deploying the anchors 104, and an act ofdeploying the anchors may drive the anchors into the adjacent tissue. Apositioning tool may facilitate expansion and/or properpositioning/orientation of the annuloplasty ring 100 against the heartvalve annulus. A stabilizer, such as a tri-pod tool or a bi-pod tool,shown for example in FIGS. 12A-12E, 13A-13D, and 14A-14B and describedin greater detail herein, may be used to position the annuloplasty ring100 in abutment against the annulus of the target heart valve, orotherwise in intimate contact with the annulus of the target heartvalve. In addition, fluoroscopy, ultrasound, and/or other imagingtechniques may be used to assist in proper positioning of theannuloplasty ring 100 against the heart valve annulus.

Although not shown in FIGS. 1A and 1B, certain ring embodiments mayinclude a selectively adjustable member for changing the size and/orshape of the annuloplasty ring 100 postoperatively to compensate forchanges in the size of the heart and/or the treated heart valve. Anillustrative example of an adjustable member may be a member made of amaterial that can be adjusted via the application of energy, such as,for example RF energy, light energy, or thermal energy.

FIG. 1C depicts a schematic diagram of an illustrative cutting pattern,generally designated 116, used for laser processing a hypotube to form abody member 101 of an adjustable annuloplasty ring 100 according to anembodiment. The pattern 116 may enable a hypotube or outer tube (alsoreferred to herein as an “outer hollow member”) to be cut for use as abody member 101 of an annuloplasty ring 100 according to an embodiment.The cutting pattern 116 may correspond to the entire body member 101 asif the body member were cut along a longitudinal axis and unrolled. Thecutting pattern 116 may enable cutting the hypotube to form theplurality of regions 102 and the integral biasing 101 elements 103. Thecutting pattern 116 shown in FIG. 1C may define the configuration of theplurality of regions 102 and how the regions 102 interact with adjacentregions as the body member 101 transitions from the elongate insertiongeometry shown to the annular operable geometry.

The cutting pattern 116 may also enable cutting the hypotube to form oneor more holes 120, 121 at each end to allow one or more pins (not shown)to couple male and/or female components of the ring closure lock 106 torespective ends of the body member 101. The cutting pattern 116 may alsoenable cutting the hypotube to form anchor windows 110 through which theplurality of anchors 104 may be deployed.

FIG. 2A depicts a schematic diagram of a perspective view of anillustrative adjustable annuloplasty ring, generally designated 200,according to an embodiment. The annuloplasty ring 200 may be in anannular (D-shaped) operable geometry and a contracted state. FIG. 2Bdepicts a schematic diagram of a perspective view of an illustrativeadjustable annuloplasty ring 200 in an expanded state. The annuloplastyring 200 may be configured to enable percutaneous, transcatheterannuloplasty to repair a heart valve.

Referring collectively to FIGS. 2A and 2B, the annuloplasty ring 200 mayinclude a body member 201 having a plurality of regions 202 a, 202 b,202 c (collectively 202), biasing elements 203 a, 203 b (collectively203), a plurality of anchors 204, a ring closure lock 206, and a pivot208. The body member 201 may be a “D-shape” in the operable geometry,but those having ordinary skill in the art will recognize that otherannular-shaped operable geometries may also be used without departingfrom the scope of the present disclosure. For example, circular or ovaloperable geometries may be used. Different from the annuloplasty ring100 of FIGS. 1A-1B, the ring closure lock 206 may be disposed on theanterior side of the annuloplasty ring 200 (rather than the posteriorside).

In addition to the operable geometry shown in FIGS. 2A and 2B, the bodymember 201 may be transitionable from an elongate insertion geometry(see, for example, FIG. 9C) to the annular operable geometry shown inFIGS. 2A and 2B. The elongate insertion geometry may allow theannuloplasty ring 200 to be inserted into and passed through a catheterfor percutaneous passage of the annuloplasty ring into the heart of apatient. A transition from an elongate insertion geometry to an annularoperable geometry is illustrated in FIGS. 9C-9F, and discussed hereinwith reference to the same.

Once in an annular operable geometry, the annuloplasty ring 200 may havea contracted state as shown in FIG. 2A and an expanded state as shown inFIG. 2B. The biasing elements 203 may be configured to allow expansionof the body member 201 to increase the A-P distance of the annuloplastyring 200 to an expanded state. In situ within the heart, expansion ofthe body member 201 to the expanded state may enlarge the annuloplastyring 200 to a size conforming, or approximately conforming, to anannulus of a target heart valve to be repaired. Expansion of the bodymember 201 may be accomplished by an expansion tool, such as a balloon,a cage, or another expansion tool, such as is shown in FIGS. 10, 11,12A-12E, 13A-13D, and 14A-14B, and described in greater detail herein.In the illustrated embodiment of FIGS. 2A and 2B, a biasing element 203a disposed between a first anterior region 202 a and a posterior region202 c and a biasing element 203 b disposed between a second anteriorregion 202 b and the posterior region 202 c may enable a desiredexpansion from the contracted state shown in FIG. 2A to the expandedstate shown in FIG. 2B.

The expanded state of FIG. 2B may be such that the annuloplasty ring 200is disposed in abutment with, or in intimate contact with, the annulusof the target valve. Disposing the annuloplasty ring 200 in intimatecontact with the annulus may enhance an anchoring process in which theplurality of anchors 204 is deployed to fasten the annuloplasty ring 200to the annulus.

Once the annuloplasty ring 200 is fastened to the annulus, it may becontracted from the expanded state of FIG. 2B back to the contractedstate of FIG. 2A to reduce a diameter of the annulus of the targetvalve. Contraction of the annuloplasty ring 200 may include the firstand second anterior regions 202 a, 202 b of the body member 201 movingin a telescopic manner into the posterior region 202 c as the biasingmembers 203 force movement of the first and second anterior regions ofthe body member toward the posterior region. Contraction of theannuloplasty ring 200 from the expanded state to the contracted statemay decrease the A-P distance of the annuloplasty ring and, with theplurality of anchors 204 securing the annuloplasty ring to the annulus,may also decrease the A-P distance of the target valve to improveleaflet coaptation and reduce regurgitation through the target valve.

In the illustrated embodiment of FIGS. 2A and 2B, contraction of theannuloplasty ring 200 from the expanded state to the contracted statemay be accomplished by the biasing elements 203. The biasing elements203 may bias the annuloplasty ring 200 toward the contracted state suchthat expansion of the annuloplasty ring 200 to the expanded state storespotential energy in the biasing elements. Releasing the biasing elements203 (for example, releasing or otherwise removing an expansion tooland/or expansion force) releases the stored potential energy and therebyforces movement of the first anterior region 202 a and the secondanterior region 202 b of the body member 201 toward the anterior region202 c of the body member to decrease the A-P distance of theannuloplasty ring 200 to the contracted state. In other words, thebiasing elements 203, upon release, may actively transition theannuloplasty ring 200 from an expanded state to the contracted state.

The biasing elements 203 of the illustrated annuloplasty ring 200 ofFIGS. 2A and 2B may include springs or another similar element that isnonintegral to the body member. The springs of the biasing elements 203may allow the anterior regions 202 a, 202 b to move away from the firstposterior region 202 c, thereby increasing the A-P distance of theannuloplasty ring 200.

The A-P distance AP1 of the contracted state of FIG. 2A may be enlargeda distance d upon expansion of the annuloplasty ring 200 such that theA-P distance AP2 of the expanded state FIG. 2B is larger (AP2 = AP1 +d). The springs of the biasing elements 203 may be biased toward arelaxed position, or the contracted state as shown in FIG. 2A, such thatexpansion of the springs stores potential energy and release of thesprings results in a release of potential energy and contraction towardthe contracted state.

In various embodiments, the plurality of anchors 204 may be configuredto secure the annuloplasty ring 200 to the annulus of the heart valve.In FIGS. 2A and 2B, the anchors 204 may be curved in the illustrateddeployed configuration. The anchors 204 in other embodiments may includeother shapes, such as, for example, linear or helical deployedconfigurations. In certain embodiments, the anchors 204 may include ashape memory material (such as, for example, nitinol) that is heat setto a deployed configuration (for example, curved configuration, linearconfiguration, or helical configuration). Those with ordinary skill inthe art will recognize that combinations of different deployed anchorconfigurations may also be used without departing from the scope of thepresent disclosure.

The anchors 204 may be superelastic such that applying sufficient stressplaces the anchors into an introduction configuration and releasing thestress allows the anchors to resume their respective deployedconfigurations. In certain embodiments, the anchors 204 may lay flatagainst the body member 201 in the introduction configuration duringinsertion of the annuloplasty ring 200 through the catheter. Asdiscussed below, in other embodiments, the anchors 204 may retractinside a hollow body member 201 of the annuloplasty ring 200 in theintroduction configuration during insertion of the annuloplasty ringthrough the catheter. In such embodiments, the anchors 204 may beselectively deployed at a desired time (for example, after theannuloplasty ring 200 is properly positioned against, or in abutmentwith, the annulus of the heart valve). In certain embodiments, thesuperelastic property of the anchors 204 may be used to self-propel theanchors into the annulus of the heart valve.

The ring closure lock 206 may be used to secure two open ends of theannuloplasty ring 200 to form a closed ring of the operable geometry.Different from the annuloplasty ring 100 of FIGS. 1A-1B, the ringclosure lock 206 may be disposed on the anterior side of theannuloplasty ring 200 (rather than the posterior side). In certainembodiments, the ring closure lock 206 may include a female snap and amale snap. The annuloplasty ring 100 may be “snap locked” using wires orsutures to pull a male snap into a female snap.

The pivot 208 may facilitate rotation of the annuloplasty ring 200 afterit exits the catheter within the heart to align the plane of theannuloplasty ring (in the annular operable geometry) with the plane ofthe heart valve, as previously described herein.

FIG. 3A depicts a schematic diagram of a perspective view of anillustrative adjustable annuloplasty ring 300 according to anotherembodiment. The annuloplasty ring 300 may be in an annular (D-shaped)operable geometry and an expanded state. FIG. 3B depicts a schematicdiagram of a perspective view of the adjustable annuloplasty ring 300 ofFIG. 3A in a contracted state. The annuloplasty ring 300 may beconfigured to enable percutaneous, transcatheter annuloplasty to repaira heart valve.

Referring collectively to FIGS. 3A and 3B, the annuloplasty ring 300 mayinclude a body member 301 having a plurality of regions 302 a, 302 b,302 c (collectively 302), a plurality of anchors 304, a ring closurelock 306, and a pivot 308, similar to previously described embodiments.The annuloplasty ring 300 may be transitionable from an elongateinsertion geometry (see, for example, FIG. 9C) to the annular operablegeometry shown in FIGS. 3A and 3B. The elongate insertion geometry mayallow the annuloplasty ring 300 to be inserted into and passed through acatheter for percutaneous passage of the annuloplasty ring into theheart of a patient, as illustrated in FIGS. 9C-9F and discussed ingreater detail herein.

The plurality of regions 302 of the illustrated annuloplasty ring 300 ofFIGS. 3A and 3B may be separate, individual segments. The segments 302may be coupled together by stepped connectors 330 a, 330 b (collectively330) in the annular operable geometry. The stepped connectors 330 may beconfigured to enable the body member 301 to be adjustable to decreasethe A-P distance of the annuloplasty ring 300 from an expanded state asshown in FIG. 3A to a contracted state as shown in FIG. 3B. The steppedconnectors 330 may initially couple the posterior segment 302 c to eachof a first anterior segment 302 a and a second anterior segment 302 b inthe expanded state of FIG. 3A, conforming, or approximately conforming,to an annulus of a target heart valve to be repaired. The expanded stateof FIG. 3A may be such that the annuloplasty ring 300 is disposed inabutment with, or in intimate contact with, the annulus of the targetvalve, thereby enhancing an anchoring process in which the plurality ofanchors 304 are deployed to fasten the annuloplasty ring to the annulus.

Once the annuloplasty ring 300 is fastened to the annulus, it may becontracted from the expanded state of FIG. 3A to the contracted state ofFIG. 3B to reduce a diameter of the annulus of the target valve.Contraction of the annuloplasty ring 300 may include the steppedconnectors 330 moving in a telescopic manner into the posterior region302 c as the first and second anterior regions 302 a, 302 b of the bodymember 301 move toward the posterior region. Contraction of theannuloplasty ring 300 from the expanded state to the contracted statemay decrease the A-P distance of the annuloplasty ring and, with theplurality of anchors 304 securing the annuloplasty ring 300 to theannulus, may also decrease an A-P distance of the target valve toimprove leaflet coaptation and reduce regurgitation through the targetvalve. The stepped connectors 330 may allow for multiple degrees ofadjustment. For example a stepped connector having two engagement steps(see engagement steps 402 in FIGS. 4A and 4B) may allow two degrees ofadjustment, as discussed in greater detail herein.

In the illustrated embodiment of FIGS. 3A and 3B, contraction of theannuloplasty ring 300 from the expanded state to the contracted statemay be accomplished percutaneously through use of sutures or wires toforce the posterior segment 302 c toward the first and second anteriorsegments 302 a, 302 b and vice versa.

In certain embodiments, a biasing element (not shown in FIGS. 3A and 3B)may bias the annuloplasty ring 300 toward the contracted state and aidin contraction of the annuloplasty ring 300 from the expanded state tothe contracted state. In other embodiments, a biasing element may enableexpansion from an initial state to an expanded state, and a steppedconnector 330 may operate to ensure expansion from the contracted stateis restricted.

Different from the embodiments of FIGS. 1A-1C and 2A-2B, theannuloplasty ring 300 of FIGS. 3A and 3B may initially be in an expandedstate upon transition to the annular operable geometry. In other words,the initial A-P distance AP1 of the annuloplasty ring 300 may besufficient to conform or substantially conform to the A-P distance of atarget valve. The A-P distance AP1 of the expanded state of FIG. 3A maybe decreased a distance d upon contraction of the annuloplasty ring 300such that the A-P distance AP2 of the contracted state FIG. 3B issmaller (AP2 = AP1 - d). The decrease of the A-P distance, with theanchors fastening the annuloplasty ring 300 to the annulus of the valve,may decrease the A-P distance of the target valve to improve leafletcoaptation of the target valve and reduce regurgitation through thetarget valve.

FIGS. 4A and 4B depict a perspective view and a cross-sectional view,respectively, of a male component 400 of a stepped connector 330 of anadjustable annuloplasty ring 300 according to an embodiment. Acorresponding female component (not shown) may be configured to receivethe male component 400 to form the stepped connector 330. The steppedconnector 330 may include two engagement steps 402 a, 402 b(collectively 402) to allow two degrees of adjustment and/or gradualadjustment. As shown in FIG. 4B, a cable 404 or suture may couple to themale component 400 of the stepped connector 330. The cable 404 or suturemay enable a force to move the male component 400 in a telescopic mannerinto a female component of the stepped connector 330. Contraction of theannuloplasty ring 300 until engagement of a first engagement step 402 awithin the female component may secure the annuloplasty ring in apartial contracted state. Further contraction of the annuloplasty ring300 to engagement of a second engagement step 402 b within the femalecomponent may secure the annuloplasty ring in the contracted state. Inthis manner, the stepped connector 330 may enable two degrees ofadjustment (and for gradual adjustment) of the A-P distance of theannuloplasty ring.

FIG. 5A depicts a schematic diagram illustrating a side view of anillustrative internal anchor ribbon 500 including the curved anchors 104shown in FIGS. 1A and 1B according to an embodiment. In certainembodiments, deployment of the anchors 104 may be accomplished using aninternal anchor member, such as anchor ribbon 500, that is selectivelymovable within a hollow tube of the body member 101 (FIG. 1A). Thecurved anchors 104 may be affixed (for example, laser welded) to theinternal anchor ribbon 500 or directly cut into the internal anchorribbon. Like the anchors 104, the internal anchor ribbon 500 may includea superelastic shape memory material (such as, for example, nitinol).The shape memory of the anchor ribbon 500 may be heat set to the samememorized annular shape as the plurality of regions 102 of the bodymember 101 in the contracted state of the annular operable geometry, asshown in FIG. 1A.

The internal anchor ribbon 500 may be slidable (for example, using wiresor sutures accessible through the catheter) in the hollow body member101 of the annuloplasty ring 100. To reduce friction between theinternal anchor ribbon 500 and the body member 101, certain ringembodiments may include an internal glide ribbon 510. The internal glideribbon 510 may include a low-friction material (for example, as acoating or covering) such as polytetrafluoroethylene (PTFE) or otherpolymer. In addition, or in other embodiments, the internal glide ribbon510 may include a superelastic shape memory material (such as, forexample, nitinol) that is heat set to the same memorized annular shapeas the body member 101. Thus, in particular embodiments, three D-shapedsuperelastic members (the outer tube of the body member 101, theinternal anchor ribbon 500, and the internal glide ribbon 510) may beincluded, which may cooperate to increase the rigidity of theannuloplasty ring 100.

In various embodiments, as shown in FIGS. 5F and 5G, the internal anchorribbon may be a tube-like polymeric element 502 having a curved wall 503and an opening 504 therethrough. In some embodiments, the polymericelement 502 may be located inside the ring 101 (FIGS. 1A and 1B) suchthat the anchors 104 (FIGS. 5A-5C) slide inside the ring. The generalshape and/or pattern of the polymeric element 502 is not limited by thisdisclosure, and may generally be any pattern that allows for movement ofthe anchors 104 (FIGS. 5A-5C) inside the ring 101 (FIGS. 1A and 1B), asdescribed herein. For example, FIGS. 5H, 5I, and 5J depict a top view, afirst side view, and a second side view, respectively, of anillustrative pattern for a polymeric element 502. The polymeric material502 may generally be made of any material now known or later developedto reduce friction and facilitate sliding of the anchors 104 (FIGS.5A-5C) within the ring. Illustrative materials may include, but are notlimited to, polytetrafluoroethylene (PTFE), fluorinated ethylenepropylene (FEP), polyether block amide (PEBA), and/or the like. Inaddition, the polymeric element 502 may be constructed by any method nowknown or later developed, including, but not limited to, an extrusionmethod, an injection molding method, a machining method, and/or thelike.

FIG. 5B depicts a schematic diagram of a top view of the anchors 104 cutinto the internal anchor ribbon 500 shown in FIG. 5A in the elongateinsertion geometry according to an embodiment. In some embodiments, alaser may be used to cut the anchors 104 along a first side 512, asecond side 514 (for example, in a pointed or tip shape), and a thirdside 516, while leaving a fourth side 518 of the anchor 104 uncut andattached to the internal anchor ribbon 500. After cutting, the anchors104 may be heat set to the desired memorized shape for the deployedconfiguration. For example, FIG. 5C depicts a schematic diagram of aside view of the internal anchor ribbon 500 in the elongate insertiongeometry and the anchors 104 in a curled or curved deployedconfiguration according to an embodiment. The amount of curvature in thedeployed configuration of the anchors 104 may depend on the particularapplication. In the example shown in FIG. 5C, the anchors 104 may foldback on themselves such that the prong or tip 520 points parallel to oraway from the internal anchor ribbon 500. FIG. 5D depicts a schematicdiagram of a top view of the internal glide ribbon 510, and FIG. 5Edepicts a schematic diagram of a side view of the internal glide ribbon510, in the elongate insertion geometry according to an embodiment.

FIGS. 6A and 6B depict schematics of cross-sectional side views of anannuloplasty ring 600 before (FIG. 6A) and after (FIG. 6B) deployment ofthe anchors 104 shown in FIGS. 5A-5C according to an embodiment. Forillustrative purposes, the annuloplasty ring 600 in FIGS. 6A and 6B isshown in an elongate insertion geometry. Those having ordinary skill inthe art will recognize, however, that the anchors 104 may generally bedeployed when the annuloplasty ring 600 is in the annular operablegeometry without departing from the scope of the present disclosure.

The illustrated annuloplasty ring 600 may include an outer tube 610 (forexample, formed by the body member 101 shown in FIG. 1 ) including aplurality of anchor deployment windows 612. During the manufacturing ofthe annuloplasty ring 600, and before the annuloplasty ring is loadedinto the catheter, the internal anchor ribbon 500 and the internal glideribbon 510 may be inserted into the outer tube 610 in a position wherethe anchors 104 are prevented from exiting through the windows 612. Asshown in FIG. 6A, inserting the internal anchor ribbon 500 into theouter tube 610 may prevent the anchors from assuming their fully curveddeployed configuration.

For deploying the anchors 104, the internal anchor ribbon 500 mayinclude (or may be attached to) a hook or loop 614 for engaging a wireor suture 616 that may be pulled by a user through the catheter (forexample, in the direction of arrow 618 in FIG. 6A) to move the tip ofeach anchor 104 to a corresponding window 612. In particularembodiments, the anchors 104 and windows 612 may be arranged such thatthe tip of each anchor 104 reaches its respective window 612 atsubstantially the same time as the other anchor/window pairs. As shownin FIG. 6B, once the tips of the anchors 104 reach the respectivewindows 612, the superelasticity of the anchors may propel the internalanchor ribbon 500 in the opposite direction (as indicated by arrow 620)as the anchors spring out the windows (as indicated by arrow 622) toresume their curved configurations. As the anchors 104 drive through thewindows 612 the anchors may drive into surrounding tissue (for example,the heart valve annulus). The superelasticity of the anchors 104 mayallow the anchors to be self-propelled into the tissue adjacent orproximate to the annuloplasty ring 600.

In some embodiments, as shown in FIG. 6C, the anchors 104 may be dividedinto a plurality of segments 650 a, 650 b, 650 c. While FIG. 6C depicts3 segments, those having ordinary skill in the art will recognize thatany number of segments may be used without departing from the scope ofthe present disclosure. For example, the anchors 104 may be divided into2 segments, 3 segments, 4 segments, 5 segments, 6 segments, or more.Dividing the anchors 104 into a plurality of segments 650 a, 650 b, 650c may allow for actuation of one or more of the segments at a time suchthat the actuated segment deploys its respective anchor(s) 104 while theremaining anchors remain non-deployed. In some embodiments, varioussegments 650 a, 650 b, 650 c may be actuated sequentially. In otherembodiments, various segments 650 a, 650 b, 650 c may be actuatedsimultaneously. In some embodiments, various segments 650 a, 650 b, 650c may be actuated based upon which anchors 104 an operator desires todeploy, which may be based upon positioning and location of theannuloplasty ring. In some embodiments, the segments 650 a, 650 b, 650 cmay be arranged in a plurality of zones. For example, a posterior sidemay be a first zone having a first plurality of segments and an anteriorside may be a second zone having a second plurality of segments. Thus,the anterior zone may be deployed separately from the posterior zone, orat substantially the same time.

FIG. 7 depicts a simplified schematic diagram of a side view of anillustrative internal anchor member (or members) 700 including linearanchors 710 according to an embodiment. The linear anchors 710 may beaffixed (for example, laser welded) to the internal anchor member 700.In the embodiment shown in FIG. 7 , however, the internal anchor member700 and linear anchors 710 may be cut from a single superelastic shapememory (such as, for example, nitinol) hypotube. FIG. 7 , for example,shows remaining tubular portions 712 after the hypotube is cut to formprongs 714 of the linear anchors 710. The remaining tubular portions 712may facilitate sliding (for example, using wires or sutures accessiblethrough the catheter) the internal anchor member 700 coaxially withinthe hollow tube of the annuloplasty ring (for example, within theannuloplasty ring 600 shown in FIGS. 6A and 6B).

The internal anchor member 700 may be heat set to the same memorizedannular shape as the annuloplasty ring 600. The anchor prongs 714 may beheat set to protrude outward through windows cut in the annuloplastyring 600. Barbs 716 may be laser welded to the prongs 714 to form thelinear anchors 710. The linear anchors 710 may be retracted/deployed bysliding the internal anchor member 700 within the annuloplasty ring 600.

As described herein, the annuloplasty ring may be configured forpercutaneous transcatheter delivery and fixation to heart valves. Theannuloplasty ring may be delivered through a catheter to the mitralvalve, for example, using a trans-septal approach, a retrogradeapproach, or a trans-apical approach. For example, FIG. 8A depicts aschematic diagram of an illustrative trans-septal approach forendovascular delivery of an annuloplasty ring (not shown) to the mitralvalve 810 of a heart 800 according to an embodiment. For illustrativepurposes, a partial cross-section of the heart 800 is illustrated toshow the right atrium RA, right ventricle RV, left atrium LA, and leftventricle LV. For clarity, certain features (for example, papillarymuscles and chordae tendineae) are not shown. In the trans-septalapproach shown in FIG. 8A, the left atrium LA may be approached byadvancement of a catheter 812 through the inferior vena cava 814, intothe right atrium RA, across the interatrial septum 816, and into theleft atrium LA. The annuloplasty ring may be delivered through thecatheter 812 into the atrium and anchored to the annulus of the mitralvalve 810.

As shown in FIG. 8A, the catheter 812 may be delivered percutaneouslyinto the heart 800. A guiding sheath (not shown) may be placed in thevasculature system of the patient and used to guide the catheter 812 andits distal end 818 to a desired deployment site. In some embodiments, aguide wire (not shown) may be used to gain access through the superioror inferior vena cava 814, for example, through groin access fordelivery through the inferior vena cava 814. The guiding sheath may beadvanced over the guide wire and into the inferior vena cava 814 shownin FIG. 8A. The catheter 812 may be passed through the right atrium RAand toward the interatrial septum 816. Once the distal end 818 of thecatheter 812 is positioned proximate to the interatrial septum 816, aneedle or piercing member (not shown) is advanced through the catheter812 and used to puncture the fossa ovalis or other portion of theinteratrial septum 816. In some embodiments, the catheter 812 may bedimensioned and sized to pass through the fossa ovalis without requiringa puncturing device. That is, the catheter 812 may pass through thenatural anatomical structure of the fossa ovalis into the left atriumLA.

Similarly, any chamber (LV, RV, LA, RA) of the heart 800 may beapproached through the inferior vena cava 814. For example, the rightventricle RV may be approached through the inferior vena cava 814, intothe right atrium RA, and through the tricuspid valve 820. A variety ofother endovascular approaches may also be used.

FIG. 8B depicts a schematic diagram of an illustrative retrogradeapproach of an annuloplasty ring (not shown) to the mitral valve 810 ofa heart 800 according to another embodiment. In FIG. 8B, a femoralapproach is shown wherein the delivery catheter 812 may be advancedthrough the aorta 822 and the aortic valve 824. Typically, the catheter812 may be advanced through a sheath positioned within the femoralartery (not shown). Under fluoroscopy or other methods of guidance, thedistal end of the catheter 812 may be guided within the left ventricleLV and turned (for example, as shown with a “U-turn” 826) within theleft ventricle LV so as to pass through the leaflets of the mitral valve810 and into the left atrium LA. After verification of the appropriatepositioning of the catheter 812, a guide wire (not shown) may beinserted through the catheter 812 into the left atrium LA, which may beused to guide one or more other catheters into the left atrium LA fordelivering and anchoring the annuloplasty ring to the annulus of themitral valve 810.

FIG. 8C depicts a schematic diagram of an illustrative trans-apicalapproach of an annuloplasty ring (not shown) to the mitral valve 810 ofa heart 800 according to another embodiment. As shown in FIG. 8C, thecatheter 812 may pass through the apex 830 of the heart 800, through theleft ventricle LV, through the leaflets of the mitral valve 810, andinto the left atrium LA. The annuloplasty ring may be delivered throughthe catheter 812 into the left atrium LA and anchored to the annulus ofthe mitral valve 810. In an embodiment, a needle or trocar may be usedto puncture through the apex 830 to create a small opening through whicha guide wire (not shown) can be inserted through the left ventricle LVinto the left atrium LA. The guide wire may be used to guidesuccessively larger and stiffer catheters so as to gradually increasethe size of the opening in the apex 830 of the heart 800.

Additionally, an annuloplasty ring may be applied to the mitral valvevia a trans-atrial approach, in which a catheter is introduced into theleft atrium in a direct approach from the right atrium (not shown).

FIG. 9A depicts a flow diagram of a first illustrative method of placingan annuloplasty ring at a target valve according to an embodiment. Themethod may include inserting 960 a distal end of a catheter into atarget tissue, such as the heart. The method of insertion 960 is notlimited by this disclosure and may be any method, particularly methodsdescribed herein with respect to FIGS. 8A-8C. The annuloplasty ring maybe inserted 962 in the proximal end of the catheter and advanced 964through the catheter and out of the distal end such that it is placed atthe location of the target tissue. In some embodiments, advancing 964may include guiding the annuloplasty via the delivery system describedherein. When the annuloplasty ring is inserted 962 and advanced 964, itmay be in an elongate insertion geometry, as described in greater detailherein. As the ring advances 964 out of the catheter, it may be allowed966 to transition to an annular operable geometry, as described ingreater detail herein. In some embodiments, advancing 964 and/orallowing 966 the annuloplasty ring may include manipulating a ringclosure knob located on a deployment handle, as described in greaterdetail herein.

The ends of the annuloplasty ring may be drawn 968 together, such as,for example, by pulling a first suture connected to the annuloplastyring through the catheter. In some embodiments, the ends may be drawn968 together via manipulating a ring closure knob located on adeployment handle, as described in greater detail herein. In someembodiments, a ring closure lock may lock the two ends of the ringtogether once they have been sufficiently drawn 968 together. In someembodiments, drawing 968 the ends together may further includemanipulating a ring snap knob on a deployment handle to cause the endsto snap together, as described in greater detail herein.

In various embodiments, a determination 970 may be made as to whetherthe ring is sufficiently oriented. In some embodiments, orientation ofthe ring may be based on the positioning and/or location of thecatheter, the location and/or positioning of the target tissue, theshape of the ring, and/or the like. If orientation of the ring isnecessary, the ring may be oriented 972. Orienting 972 may include, forexample, rotating the ring, the catheter, and/or various othercomponents described herein. In some embodiments, orienting 972 mayinclude automatically rotating the ring to change a plane of the ringfrom a first orientation that is parallel to the catheter to a secondorientation that is parallel to a plane of the annulus. In someembodiments, orienting 972 the annuloplasty ring may be completed viathe stabilizer portion, such as by manipulating a stabilizer knob on adeployment handle, as described in greater detail herein.

In various embodiments, a determination 974 may be made as to whetherthe ring is sufficiently expanded. In some embodiments, expansion of thering may be based on the construction of the ring, as described ingreater detail herein. Thus, in some embodiments, expansion may notoccur, particularly in embodiments where the ring is not expandable, asdescribed in greater detail herein. If expansion of the ring isnecessary, the ring may be expanded 976. Expansion of the ring may becompleted by manipulating one or more sutures, as described in greaterdetail herein. In some embodiments, expanding 976 the ring may becompleted via an expansion tool, such as, for example, by manipulatingan expansion tool knob on a deployment handle, as described in greaterdetail herein. In some embodiments, a percutaneously,transcatheter-operated expansion tool may be actuated to expand 976 theannuloplasty ring in the annular operable geometry to an expanded stateto thereby increase an A-P distance of the annuloplasty ring. Expansionof the annuloplasty ring may include expanding a biasing element of theannuloplasty ring.

In various embodiments, a determination 978 may be made as to whetherthe ring is contacting the annulus. The determination 978 may benecessary, for example, to ensure proper placement of the ring adjacentto the annulus. In some embodiments, the ring may be pressed 980 againstthe annulus. Pressing 980 may include positioning the annuloplasty ringin abutment or similar relatively intimate contact with an annulus of atarget valve to enhance a process of fastening the annuloplasty ring tothe annulus. The method may include manipulating a stabilizer, such asvia a stabilizer knob, as described in greater detail herein. The methodmay also include pulling a second suture connected to the annuloplastyring through the catheter to deploy 982 a plurality of tissue anchorsfrom the annuloplasty ring. Deployment 982 of the anchors may also becompleted via manipulation of an anchor deployment knob, as described ingreater detail herein. With the anchors deployed 982 and theannuloplasty ring fastened to the tissue of the target valve, theexpansion tool may be released 984. The annuloplasty ring may becontracted 986 to transition the annuloplasty ring in the operablegeometry to a contracted state to decrease the A-P distance, therebydecreasing the A-P distance of the target heart valve to improvecoaptation and reduce regurgitation through the target heart valve. Insome embodiments, contraction 986 of the annuloplasty ring may becompleted by biasing elements that have stored potential energy duringexpansion of the annuloplasty ring.

In various embodiments, the annuloplasty ring may be detached 988 fromthe catheter and the first and second sutures, and the catheter may beremoved 990 from the heart. In some embodiments, the ring may bedetached 988 via manipulation of a ring release knob on a deploymenthandle, as described in greater detail herein.

FIG. 9B depicts a flow diagram of a second illustrative method ofplacing an annuloplasty ring at a target valve according to anembodiment. The method may include inserting 1050 a distal end of acatheter into a target tissue, such as the heart. The method ofinsertion 1050 is not limited by this disclosure and may be any method,particularly methods described herein with respect to FIGS. 8A-8C. Theannuloplasty ring may be inserted 1052 in the proximal end of thecatheter and advanced 1054 through the catheter and out of the distalend such that it is placed at the location of the target tissue. In someembodiments, advancing 1054 may include guiding the annuloplasty via thedelivery system described herein. When the annuloplasty ring is inserted1052 and advanced 1054, it may be in an elongate insertion geometry, asdescribed in greater detail herein. In some embodiments, theannuloplasty ring may be attached to a catheter. As the ring advances1054 out of the catheter, it may be allowed 1056 to transition to anannular operable geometry, as described in greater detail herein. Insome embodiments, advancing 1054 and/or allowing 1056 the annuloplastyring may include manipulating a ring closure knob located on adeployment handle, as described in greater detail herein.

The ends of the annuloplasty ring may be drawn 1058 together, such as,for example, by pulling a first suture connected to the annuloplastyring through the catheter. In some embodiments, the ends may be drawn1058 together via manipulating a ring closure knob located on adeployment handle, as described in greater detail herein. In someembodiments, a ring closure lock may lock the two ends of the ringtogether once they have been sufficiently drawn 1058 together. In someembodiments, drawing 1058 the ends together may further includemanipulating a ring snap knob on a deployment handle to cause the endsto snap together, as described in greater detail herein.

The annuloplasty ring may be contacted 1060 with a posterior side of thevalve. Such contacting 1060 may generally be completed via the deliverysystem, as described in greater detail herein. Use of the deliverysystem may include manipulating at the stabilizer, as described ingreater detail herein. A first portion of the anchors may be deployed1062, such as, for example, the posterior zone anchors (as describedherein). Thus, in some embodiments, anchors located in two posteriorzones may be deployed sequentially. Alternatively, anchors located intwo posterior zones may be deployed simultaneously. Deployment 1062 mayeffect engagement of the one or more posterior zones of the annuloplastyring (or a portion thereof) to the posterior side of the valve. Aspreviously described herein, deployment 1062 may be completed viamanipulation of an anchor deployment knob.

The valve tissue may be dragged 1064, via the delivery system, such thatthe annuloplasty ring may be contacted 1066 to the anterior side of thevalve. Use of the delivery system may include manipulating at least thestabilizer, as described in greater detail herein. A second portion ofthe anchors may be deployed 1068, such as, for example, the anteriorzone anchors (as described herein). Thus, in some embodiments, anchorslocated in two anterior zones may be deployed sequentially.Alternatively, anchors located in two anterior zones may be deployedsimultaneously. Deployment 1068 may effect engagement of the anteriorzone of the annuloplasty ring (or a portion thereof) to the anteriorside of the valve.

With the anchors deployed 1062, 1068 and the annuloplasty ring fastenedto the tissue of the target valve, the stabilizer may be released 1070.The annuloplasty ring may be contracted 1072 to transition theannuloplasty ring in the operable geometry to a contracted state todecrease the A-P distance, thereby decreasing the A-P distance of thetarget heart valve to improve coaptation and reduce regurgitationthrough the target heart valve. In some embodiments, contraction 1072 ofthe annuloplasty ring may be completed by biasing elements that havestored potential energy during expansion of the annuloplasty ring.

In various embodiments, the annuloplasty ring may be detached 1074 fromthe catheter and the first and second sutures, and the catheter may beremoved 1076 from the heart. In some embodiments, the ring may bedetached 1074 via manipulation of a ring release knob on a deploymenthandle, as described in greater detail herein.

FIGS. 9C, 9D, 9E, and 9F depict schematic diagrams illustratingtranscatheter delivery of an annuloplasty ring 902 from a deliverysystem 900 according to various embodiments. FIG. 9C depicts aperspective view of a distal end 910 of the delivery system 900. Asshown in FIG. 9C, the annuloplasty ring 902 may be in the elongateinsertion geometry and partially deployed from the distal end 910 of adelivery catheter 914 in a first deployment stage. In the first stage,the annuloplasty ring 902 may be still substantially in the elongateinsertion geometry. As shown in FIG. 9C, a first suture 919 for snappingtogether the ends of the annuloplasty ring 902 may pass through a malesnap 912 of a ring closure lock 950 (shown in FIG. 9E).

FIG. 9D is a perspective view of the annuloplasty ring 902 in a secondstage of partial deployment from the delivery catheter 914. In thesecond stage, the portion of the annuloplasty ring 902 that has exitedthe delivery catheter 914 has begun to transition (due to the shapememory materials used in the annuloplasty ring) from the elongateinsertion geometry to the annular operable geometry.

FIG. 9E is a perspective view of the annuloplasty ring 902 in a thirdstage of deployment in which a ring shuttle 916 of the delivery system900 has substantially pushed the annuloplasty ring out of the deliverycatheter 914, but the plane of the annuloplasty ring is still alignedwith (for example, parallel to) the longitudinal axis of the deliverycatheter. In FIG. 9E, the annuloplasty ring 902 may be in aconfiguration, for example, immediately before a ring deployment wire923 cooperates with the pivot 108 to rotate the annuloplasty ring 902(see FIG. 9F). In the configuration shown in FIG. 9E, the distal end ofthe ring deployment wire 923 may include a bend or hook 932 as it passesthrough a hole in the pivot 108. The ring deployment wire 923 includes asuperelastic shape memory material (such as, for example, nitinol), andbending the distal end of the ring deployment wire 923 into the hook 932shape may spring load the annuloplasty ring 902 within the outer jacketdelivery catheter 914 such that the annuloplasty ring 902 automaticallyrotates about the pivot 108 upon exiting the outer jacket deliverycatheter 914. At this third stage of deployment, the hook 932 shapeformed in the superelastic ring deployment wire 923 is ready to unload(return to a heat-set memorized straight configuration) as soon as thedelivery catheter 914 no longer prevents it from doing so. The suture919 may be used to draw together the male components 952 and femalecomponents 954 of a ring closure lock 950.

FIG. 9F depicts a perspective view of the annuloplasty ring 902 in afourth stage of deployment in which the plane of the annuloplasty ring(in its annular operable geometry) has been changed to be perpendicularto the longitudinal axis of the delivery catheter 914. As shown in FIG.9F, the superelastic ring deployment wire 923 has returned to its heatset (memorized) straight configuration. At this fourth stage ofdeployment, the plane of the annuloplasty ring 902 may be configured tobe parallel to the plane of the heart valve annulus. In situ within theheart, a longitudinal axis of the delivery catheter 914 may be orientedparallel to the direction of blood through the valve and approximatelyperpendicular to the plane of the heart valve. The annuloplasty ring902, when oriented such that the plane of the annuloplasty ring istransverse to (and perpendicular or approximately perpendicular to) thelongitudinal axis of the delivery catheter 914, may be oriented suchthat the plane of the annuloplasty ring is parallel or approximatelyparallel to the plane of the heart valve.

In further stages of deployment, the annuloplasty ring 902 may beexpanded and/or pressed against the heart valve annulus before deployingthe anchors (such as the curved anchors 104 shown in FIGS. 1A and 1B).As discussed herein, certain anchors may propel themselves into thetissue of the heart valve annulus upon being deployed. In otherembodiments, the anchors (such as the linear anchors 710 shown in FIG. 7) may be deployed before pressing the annuloplasty ring 902 against theannulus. After the annuloplasty ring 902 is anchored to the heart valveannulus and transitioned to the contracted state, the ring deploymentwire 923 may be pulled from the hole in the pivot 108 to release theannuloplasty ring 902 from the ring shuttle 916. Any remaining sutures,such as the first suture 919, may also be cut and/or pulled from theannuloplasty ring 902 before the delivery catheter 914 is removed fromthe heart. In some embodiments, removal of the ring deployment wire 923and/or any remaining sutures may be completed via one or more of theknobs, as described in greater detail herein.

FIG. 10 depicts a schematic diagram of a perspective, partialcross-sectional view of a heart 1000 during the expansion of anadjustable annuloplasty ring 1002 using an expansion tool 1004,preparatory to affixation to the annulus of the mitral valve 1006according to an embodiment. As shown in FIG. 10 , a delivery catheter1010 may extend from the left ventricle into the left atrium through theleaflets of the mitral valve 1006. Thus, this illustrated embodiment maycorrespond to, for example, a trans-apical approach or a retrogradeapproach, as discussed herein. Those with ordinary skill in the art willrecognize from the present disclosure that similar principles as thoseillustrated may be used for trans-septal approaches.

In FIG. 10 , an expansion tool 1004 may be used to expand theannuloplasty ring 1002. The annuloplasty ring 1002 may be positioned onor next to the annulus of the mitral valve 1006. The expansion tool 1004may be disposed within the annuloplasty ring 1002 (and within the targetvalve 1006) to expand the annuloplasty ring 1002 to transition it from acontracted state to an expanded state. The expansion tool 1004 of theillustrated embodiment of FIG. 10 is a balloon expansion tool 1004. Theballoon expansion tool 1004 may be inflated to expand the annuloplastyring 1002 to an expanded state. In some embodiments, the balloonexpansion tool 1004 may include a plurality of sections and may beconsidered a “multi-chamber” balloon with a plurality of chambers. Inparticular embodiments, the balloon expansion tool 1004 may have twochambers. In other embodiments, a balloon expansion tool 1004 may have asingle chamber.

In the embodiment shown in FIG. 10 , the inflated balloon expansion tool1004 may reduce or prevent the flow of blood through the mitral valveduring at least part of the implantation procedure. In such embodiments,inflation of the balloon expansion tool 1004 may last 20 seconds or lessto prevent adverse consequences of occluding the mitral valve 1006. Inother embodiments, such as the embodiment of an expansion tool shown inFIGS. 11, 12A-12E, 13A-13D, and 14A-14B, blood may be allowed to flowthrough the target valve 1006 during the entire procedure.

FIG. 11 depicts a schematic diagram of a perspective, partialcross-sectional view of a heart 1100 during the expansion of anadjustable annuloplasty ring 1102 using a cage or basket tool 1104 as anexpansion tool, preparatory to affixation to the annulus of the mitralvalve 1106 according to another embodiment.

The basket expansion tool 1104 may include a plurality of flexiblemembers 1108 that lay flat against a central rod 1114 during insertionof the basket expansion tool through the delivery catheter (see FIG. 10) and may be forced into an expanded configuration (shown in FIG. 11 )when the central rod is pushed into an end cap 1112. In anotherembodiment, each of the plurality of flexible members 1108 may include asuperelastic material so as to spring from a delivery catheter into theexpanded configuration shown in FIG. 11 .

FIGS. 12A and 12B depict schematic diagrams of perspective views of anillustrative stabilizer, generally designated 1200, that may be used inlieu of the expansion tool according to an embodiment. FIG. 12A depictsa perspective view of the stabilizer 1200 separated from othercomponents of the percutaneous annuloplasty system. FIG. 12B depicts thestabilizer 1200 disposed through a delivery catheter 1204 and engagingan annuloplasty ring 1250.

In order to achieve sufficient intimate contact between an annuloplastyring 1250 (shown in FIG. 12B) and the tissue of the target heart valve(for example, the annulus of the heart valve), the stabilizer 1200 maybe used to position, orient, and otherwise manipulate the annuloplastyring 1250 in the annular operable geometry, prior to affixation totissue of the valve. The stabilizer 1200 may have a metallic ribstructure having a plurality of arms 1202 a, 1202 b, 1202 c(collectively 1202) or prongs configured to extend outward at an anglefrom a central column 1203. While only three arms 1202 are shown in thepresent embodiment, those having ordinary skill in the art willrecognize any number of arms may be suitable without departing from thescope of the present disclosure. For example, the stabilizer 1200 mayhave 2, 3, 4, 5, 6, 7, 8, 9, 10 or more arms 1202. The rib structure,specifically the arms 1202 and central column 1203, may be laser cutfrom a shape memory material, such as nitinol. The stabilizer 1200 maybe cut from a hollow tube such that the central column 1203 has a hollowcylindrical shape. The arms 1202 may be heat set to extend at an anglefrom the central column 1203.

The illustrated stabilizer 1200 of FIGS. 12A and 12B may include threearms 1202 arranged, for example, as a tripod. The plurality of arms 1202of the stabilizer 1200 may be loaded into a delivery catheter 1204together with the annuloplasty ring 1250 (for example, configured in theelongate insertion geometry). As the arms 1202 emerge from a distal endof the delivery catheter 1204, they may automatically expand outward.The stabilizer 1200, and specifically the plurality of arms 1202, may beconfigured to align with and engage the annuloplasty ring 1250 as shownin FIG. 12B. When aligned and engaged with the annuloplasty ring 1250,the stabilizer 1200 may be used to push/pull the annuloplasty ring 1250toward the tissue of an annulus of a heart valve.

The illustrated stabilizer of FIGS. 12A and 12B may be configured toengage a top surface of the annuloplasty ring 1250, through theannuloplasty ring, to pull the annuloplasty ring downward. For example,the plurality of arms 1202 may include a curved, angled, or hookedportion at a distal end to facilitate engagement with the annuloplastyring 1250. The stabilizer 1200 may be used to pull the annuloplasty ring1250 toward the heart valve to facilitate intimate contact of theannuloplasty ring with the annulus. Intimate contact, or close abutment,of the annuloplasty ring 1250 with the annulus of the valve may enhancean anchor deployment process to fasten the annuloplasty ring 1250 to theannulus.

In some embodiments, the stabilizer 1200, particularly the arms 1202,may also be configured to function as an expansion tool to engage theannuloplasty ring 1250 and effectuate and/or facilitate transition ofthe annuloplasty ring from a contracted state to an expanded state. Forexample, a superelastic property and memorized shape of the plurality ofarms 1202 may effectuate expansion of the annuloplasty ring 1250. Thesuperelastic arms 1202 may engage an inner surface of the annuloplastyring 1250 and exert outward force to expand the annuloplasty ring. Inother embodiments, a suture or other elongate member may enablepercutaneous manipulation of one or more of the plurality of arms toeffectuate expansion of the annuloplasty ring 1250.

FIGS. 12C and 12D depict a stabilizer 1200 that includes a balloon 1280.The balloon 1280 may pass through the central column 1203 of thestabilizer 1200. When the balloon 1280 is inflated, it may cause thearms 1202 of the stabilizer 1200 to expand. By expanding the stabilizer1200, the ring 1250 (FIG. 12E) may be expanded to its expandedconfiguration. In some embodiments, the ring 1250 (FIG. 12E) may also becontracted when the balloon 1280 is deflated and the tool 1200 isretracted.

FIG. 12E depicts a schematic diagram that demonstrates how various holes1270 may be used to guide one or more sutures 1271 that exit the ring1250, as described in greater detail herein. The sutures 1271 may beused for deployment or recapturing of the anchors held within the ring1250. In some embodiments, the sutures 1271 may extend through thewindows in the ring and/or dedicated holes in the laser cut pattern ofthe ring, as described herein. The holes in the tool 1200 may allow thesutures 1271 to be gathered together and guided through the hollowcentral column 1203 and the catheter 1204 via the handle at the proximalend of the catheter, as described in greater detail herein.

In various embodiments, the expansion tool and/or the stabilizer may beconfigured to complete one or more additional tasks. Illustrativeadditional tasks are not limited by this disclosure, and may include,for example, navigating the annuloplasty ring within a chamber of aheart, creating an intimate contact between the annuloplasty ring andthe target tissue (such as a valve annulus), expanding the annuloplastyring, and stabilizing the annuloplasty ring during various deploymentand anchoring processes, as described in greater detail herein.

FIGS. 13A and 13B depict schematic diagrams of perspective views of anillustrative stabilizer 1300 to be used as an expansion tool of apercutaneous annuloplasty system according to an embodiment. Theillustrated stabilizer 1300 may include one or more arms or prongs 1302,such as, for example, two arms 1302 a, 1302 b. FIG. 13A depicts aperspective view of the stabilizer 1300 separated from other componentsof the percutaneous annuloplasty system. FIG. 13B depicts the stabilizer1300 disposed through a delivery catheter 1306 and engaging anannuloplasty ring 1350. The stabilizer 1300 may be used to position,orient, and otherwise manipulate the annuloplasty ring 1350 to achieveintimate contact in abutment with tissue of the annulus of a targetheart valve.

Referring generally and collectively to FIGS. 13A-13D, the arms 1302 ofthe stabilizer 1300 may be configured to extend outward at an angle froma central column 1304, thereby forming a rib structure. The ribstructure, particularly the arms 1302 and central column 1304, may belaser cut from a shape memory material, such as, for example, nitinol.The stabilizer 1300 may be cut from a hollow tube such that the centralcolumn 1304 has a hollow cylindrical shape. The arms 1302 may be heatset to extend at an angle from the central column 1304.

The illustrated stabilizer 1300 of FIGS. 13A and 13B may include twoarms 1302 a, 1302 b arranged, for example as a bipod. The two arms 1302a, 1302 b in cooperation with a ring shuttle 1361 of a delivery systemof the percutaneous annuloplasty system form a tripod structure engagingthe annuloplasty ring 1350 at three points. The plurality of arms 1302may be loaded into a delivery catheter 1306 together with theannuloplasty ring 1350 (for example, configured in the elongateinsertion geometry). As the arms 1302 extend from a distal end of thedelivery catheter 1306, they may automatically expand outward and may beconfigured to align with and engage the annuloplasty ring 1350 as shownin FIG. 13B. When aligned and engaged with the annuloplasty ring 1350,the stabilizer 1300 may be used to push/pull the annuloplasty ringtoward the tissue of the annulus of a valve.

The illustrated stabilizer of FIGS. 13A and 13B may be configured toengage a top surface of the annuloplasty ring 1350 to pull theannuloplasty ring. For example, the plurality of arms 1302 may include acurved, angled, or hooked portion at a distal end to facilitateengagement with the annuloplasty ring 1350. The stabilizer 1300 may beused to pull the annuloplasty ring 1350 toward the heart valve tofacilitate intimate contact of the annuloplasty ring with the annulus toenhance an anchor deployment process to fasten the annuloplasty ring tothe annulus.

The stabilizer 1300, particularly the arms 1302, may also be configuredto function as an expansion tool to engage the annuloplasty ring 1350and effectuate and/or facilitate transition of the annuloplasty ringfrom a contracted state to an expanded state. For example, asuperelastic property and memorized shape of the plurality of arms 1302may enable the arms to engage an inner surface of the annuloplasty ring1350 and via its inherent material properties, exert outward force toexpand the annuloplasty ring. In other embodiments, a suture or otherelongate member may enable percutaneous manipulation of one or more ofthe plurality of arms 1302 to effectuate expansion of the annuloplastyring 1350.

In some embodiments, the arms 1302 of the stabilizer 1300 may alsoinclude a feature that locks the stabilizer against the annuloplastyring 1350, thereby preventing each arm from moving relative to another,such as, for example, after the deployment and during creation ofintimate contact between the ring and the tissue. For example, the arms1302 of the stabilizer 1300 may each have at least one strat 1303 a,1303 b (collectively 1303). Each strat 1303 may prevent its respectivearm 1302 from sliding on the annuloplasty ring 1350 and may allow and/orfacilitate engagement on a particular position of the ring. In someembodiments, a particular position of engagement on the annuloplastyring 1350 may ensure a proper ring size, shape, and/or orientation.After aligning the stabilizer 1300 relative to the annuloplasty ring1350, the stabilizer may be fixed in relation to the ring by the strats1303. By manipulating the tool 1300, the operator may be able tomanipulate the position and orientation of the annuloplasty ring 1350.

In various embodiments, as shown in FIGS. 13E-13I, the annuloplasty ring1350 may also have at least one strat 1355 a, 1355 b (collectively1355). Each strat 1355 may prevent the annuloplasty ring 1350 fromsliding when attached to the arms 1302. In some embodiments, each strat1355 may allow and/or facilitate engagement of a particular portion ofthe annuloplasty ring 1350 with a particular arm 1302. In someembodiments, a particular position of engagement of the strats 1355 onthe annuloplasty ring 1350 may ensure a proper ring size, shape, andorientation. After aligning the stabilizer 1300 (FIG. 13C) relative tothe annuloplasty ring 1350, the stabilizer may be fixed in relation tothe ring by the strats 1355. In some embodiments, the strats 1355 on theannuloplasty ring 1350 may be used in conjunction with the strats 1303on the arms 1392 of the stabilizer. In other embodiments, the strats1355 on the annuloplasty ring 1350 may be used in lieu of the strats1303 on the arms 1392 of the stabilizer.

FIGS. 14A and 14B depict diagrams illustrating perspective views of astabilizer 1400 of a percutaneous annuloplasty system according to anembodiment. The stabilizer 1400 may be configured to push and/or pressan annuloplasty ring 1450 (from above) into intimate contact with, orabutment against, an annulus of a target heart valve. The illustratedstabilizer 1400 may include a plurality of arms or prongs 1402, such as,for example two arms 1402 a, 1402 b. FIG. 14A depicts a perspective viewof the stabilizer 1400 separated from other components of thepercutaneous annuloplasty system. FIG. 14B depicts the stabilizer 1400disposed through a delivery catheter 1406 and engaging an annuloplastyring 1450 from above. The stabilizer 1400 may be used to position,orient, and/or otherwise manipulate the annuloplasty ring 1450 toachieve intimate contact with or abutment against tissue of the annulusof a target heart valve.

The arms 1402 of the stabilizer 1400 may be configured to extend outwardat an angle from a central column 1404, thereby forming a rib structure.The rib structure, particularly the arms 1402 and central column 1404,may be laser cut from a shape memory material, such as nitinol. Thestabilizer 1400 may be cut from a hollow tube such that the centralcolumn 1404 has a hollow cylindrical shape. The arms 1402 may be heatset to extend at an angle from the central column 1404.

The illustrated stabilizer 1400 of FIGS. 14A and 14B may include twoarms 1402 a, 1402 b arranged, for example, in the shape of a bipod. Thetwo arms 1402 a, 1402 b, in cooperation with a ring shuttle 1451 of thepercutaneous annuloplasty system, may form a tripod structure engagingthe annuloplasty ring 1450 at three points. The plurality of arms 1402may be loaded into a delivery catheter 1406 together with theannuloplasty ring 1450 (for example, configured in the elongateinsertion geometry). As the arms 1402 emerge from a distal end of thedelivery catheter 1406, they may automatically expand outward and may beconfigured to align with and engage the annuloplasty ring 1450, as shownin FIG. 14B. When aligned and engaged with the annuloplasty ring 1450,the stabilizer 1400 may be used to push/pull the annuloplasty ringtoward the tissue of an annulus of a heart valve.

The illustrated stabilizer of FIGS. 14A and 14B may be configured toengage a top surface of the annuloplasty ring 1450 from above to pushthe annuloplasty ring. For example, the plurality of arms 1402 mayinclude a curved, angled, and/or hooked portion at a distal end tofacilitate engagement with the annuloplasty ring 1450. The stabilizer1400 may be used to push the annuloplasty ring 1450 from above in adownward direction toward the heart valve to facilitate intimate contactof the annuloplasty ring with the annulus to enhance an anchordeployment process and/or to aid in the fastening of the annuloplastyring to the annulus.

The stabilizer 1400, particularly the arms 1402, may also be configuredto function as an expansion tool to engage the annuloplasty ring 1450,effectuate, and/or facilitate transition of the annuloplasty ring from acontracted state to an expanded state. For example, a superelasticproperty and shape memory property of the plurality of arms 1402 mayenable the arms to engage an inner surface of the annuloplasty ring 1450and exert an outward force to expand the annuloplasty ring. Thestabilizer 1400 may be manipulated to expand the annuloplasty ring 1450within the annulus of the target valve, or otherwise press theannuloplasty ring against the valve and thereby effectuating expansionof the annuloplasty ring to the expanded state. In other embodiments, asuture or other elongated member may enable percutaneous manipulation ofone or more of the plurality of arms 1402 to effectuate expansion of theannuloplasty ring 1450.

FIG. 15A depicts a diagram of a perspective view of an illustrativeproximal end handle, generally designated 1500, of a percutaneousannuloplasty system according to an embodiment. FIG. 15B depicts adiagram of a perspective cross-sectional view of the proximal end handle1500 of FIG. 15A. In various embodiments, the proximal end handle 1500may enable percutaneous transcatheter deployment of an annuloplastyring. More particularly, the proximal end handle 1500 may enablepercutaneous manipulation of an annuloplasty system configured todeliver, configure, and/or orient an annuloplasty ring and to fasten theannuloplasty ring to the annulus of a target valve.

In various embodiments, the proximal end handle 1500 may include one ormore rotating knobs that are configured to perform or enable one or morefunctions. In some embodiments, one rotatable knob may be used for eachfunction to be performed. In other embodiments, one rotatable knob maybe used for a plurality of functions. A ring closure knob 1502 mayenable closure of the annuloplasty ring to transition from an elongatedinsertion geometry to an annular operable geometry, as described ingreater detail herein. A ring snap knob 1504 may enable snappingtogether of first and second ends (for example, distal and proximalends) of the annuloplasty ring or other manipulation of a ring closurelock, as described herein. An anchor deployment knob 1506 may enabledeployment of anchors of an annuloplasty ring to fasten the annuloplastyring to the annulus of the target heart valve, as described herein. AnA-P adjustment knob 1508 may enable contraction of the annuloplasty ringfrom an expanded state to a contracted state, as described herein. Inother embodiments, the A-P adjustment knob 1508 may also enablemanipulation of a stabilizer to facilitate expansion of the annuloplastyring to an expanded state (for example, prior to deployment of theanchors). A ring release knob 1510 may enable release of theannuloplasty ring from a delivery system and/or delivery shuttle of apercutaneous annuloplasty system. Additional or fewer knobs may bepossible, depending on the functions to be performed. Furthermore, thepositioning of each knob relative to other knobs as shown in FIG. 15A ismerely illustrative. Accordingly, those having ordinary skill in the artwill recognize other positions of each knob relative to other knobs asbeing included within the scope of this disclosure.

In various embodiments, each of the knobs 1502, 1504, 1506, 1508, 1510may be coupled to an independent system of cables and/or sutures.Manipulation of a respective cable and/or suture may be achieved byrotating the respective knob 1502, 1504, 1506, 1508, 1510. As shown inFIG. 15B, each of the knobs 1502, 1504, 1506, 1508, 1510 may bemechanically coupled to a respective translation gear mechanism. Thegear mechanism may be connected to a respective cable or suture that isconfigured to perform a given function.

FIGS. 16A and 16B depict diagrams of perspective views of anillustrative delivery system, generally designated 1600, of apercutaneous annuloplasty system, according to an embodiment. In someembodiments, the delivery system 1600 may include a plurality ofsections, such as, for example, a distal end section 1700, a cathetersection 1800, and/or a proximal handle section 1900. The delivery system1600 may be configured to enable percutaneous transcatheter deploymentof an annuloplasty ring, as described herein. More particularly, thedelivery system 1600 may enable percutaneous manipulation of anannuloplasty system configured to deliver, configure, and/or orient anannuloplasty ring. Further, the delivery system 1600 may be configuredto fasten the annuloplasty ring to the annulus of a target heart valve,as described in greater detail herein.

FIGS. 17A and 17B depict illustrative examples of a full assembly of aring 1710, a stabilizer 1730, and a distal end of the catheter 1740 asconfigured in a target site after deployment of the ring from thecatheter.FIGS. 17A and 17B further depict an illustrative example of anattachment mechanism between the ring 1710 and the stabilizer 1730. Asdescribed in greater detail herein, the connection may be accomplishedbetween a pivot point 1712 on the ring 1710 and the ring shuttle 1722 onthe stabilizer 1730 via a wire 1723 that may be configured to passthrough the catheter 1740 to the proximal end of the delivery system.

Also shown in FIGS. 17A and 17B is an illustrative example of a deliverysystem 1700 showing, at the distal end, a solid piece 1721. The solidpiece 1721 may be manufactured from any material, such as, for example,stainless steel. The solid piece 1721 may be configured for one or morefunctions. Illustrative functions may include, but are not limited to,holding the ring shuttle 1722 in a particular position, locating thestabilizer 1730 in relation to the ring shuttle and/or the ring 1710 atthe target site, and guiding the sutures from the ring through the holes1724 towards the proximal end of the delivery system 1740.

FIGS. 18A and 18B depict a longitudinal cross-sectional view of anillustrative catheter, generally designated 1800, connecting the distalend of the delivery system 1700 (FIGS. 17A and 17B) to the proximal endof the delivery system 1900 (FIGS. 19A and 19B). The catheter 1800 mayinclude one or more lumens 1810 containing, but not limited to, a hollowouter sleeve 1811 that is attached to the proximal end of the deliverysystem 1910.

In various embodiments, an inner hollow shaft 1812 may be located withinthe hollow outer sleeve 1811. Referring also to FIG. 19A, the innerhollow shaft 1812 may be connected to a moving member 1931 that isconfigured to transfer movement of a rotating knob 1932 to the innerhollow shaft 1812 and to the solid piece 1721 (FIGS. 17A and 17B) at thedistal end of the delivery system 1700 (FIGS. 17A and 17B).

In some embodiments, a stabilizer shaft 1813 may be located within theinner hollow shaft 1812. The stabilizer shaft 1813 may connect thestabilizer 1730 to the proximal end of the delivery system 1700 (FIGS.16A and 16B). In some embodiments, the stabilizer shaft 1813 may beconfigured to allow distal control of the stabilizer 1730 from theproximal end 1950 (FIG. 19A). In some embodiments, a guidewire orpig-tail catheter 1814 may be passed through the center of thestabilizer shaft 1813. The guidewire or pig-tail catheter 1814 maygenerally be one of a commonly used tool in the cardiovascular field tofunction as a guide in the heart chambers and/or to function as aconduit for injection of contrast media for fluoroscopy.

FIGS. 19A, 19B, and 19C depict an illustrative embodiment for theproximal side of the delivery system 1900, which may function as ahandle. The system 1900 may include one or more functional mechanisms.Illustrative functional mechanisms may include, but are not limited to,a ring deployment mechanism 1930, a ring closure or snapping mechanism1940, a barb or anchor deployment mechanism 1920, and control channelmechanism for the ring release wire 1723 (FIGS. 17A and 17B). The ringdeployment mechanism 1930 may include a rotating knob 1932 and/or amoving member 1931 that may be attached to the inner hollow shaft 1812.In some embodiments, the knob 1932 may be configured to be rotated suchthat the ring 1710 (FIGS. 17A and 17B) is pushed distally and awaythrough the outer sleeve 1811, thereby deploying from the catheter. Theend of the suture 1960 from the ring 1710 (FIGS. 17A and 17B) may befixed at the proximal end 1950 such that when the ring deploys, thesuture may be placed under a constant tension.

FIG. 19B depicts an illustrative suture 1960 attached to the ring 1710at the distal end 1951. The suture may pass through the proximal end ofthe ring 1715, the ring shuttle 1722, the solid piece 1721 and the outersleeve 1811 to the proximal end of the delivery system 1950 (FIG. 19A).The total length of the suture 1960 may be the length of a first portiona plus the length of a second portion b (a + b).

FIG. 19C depicts an illustrative ring 1710 after deployment from theouter sleeve 1811. As shown in FIG. 19C, the suture 1960 may remain thesame length as it is attached at the same points of the ring 1710relative to the delivery system. Accordingly, the suture 1960 may beplaced under tension.

Referring again to FIG. 19A, a channel 1920 may be provided for one ormore barb deployment elongated members (such as, for example, sutures)to be held and pulled once barbs and/or anchors are deployed, asdescribed in greater detail herein. Any number of barb deploymentmembers may be placed via the channel 1920. In some embodiments, thenumber of barb deployment members may correspond to a number of windows,as described herein. For example, 1 barb deployment member, 2 barbdeployment members, 3 barb deployment members, 4 barb deploymentmembers, 5 barb deployment members, 6 barb deployment members, 7 barbdeployment members, 8 barb deployment members, 9 barb deploymentmembers, 10 barb deployment members or more may be placed via thechannel 1920.

An annuloplasty ring, as disclosed above, may be used to adjust theshape of an annulus of a cardiovascular valve, thereby bringing itsleaflets into a functional geometry. Additionally, such a device may beused to provide a stabilizing platform for a replacement cardiovascularvalve if the natural cardiovascular valve is defective, degraded, ordiseased. Such a use may be indicated if the natural valve structure andits environment are too deformable to permit long-term placement of thereplacement valve. Natural cardiovascular valves that may be treated inthis manner may include cardiac valves or venous valves. Cardiac valvesmay include the mitral valve, the aortic valve, the tricuspid valve, andthe pulmonary valve. In the disclosure below, reference is made to anadjustable stabilizing ring that may be used in conjunction with areplacement valve. It may be understood that embodiments of such anadjustable stabilizing ring, along with the variety of systems,implements, and catheters that may be used for its deployment in thecardiovascular system, may include the embodiments of annuloplasty ringsand the systems, implements, and catheters that have been disclosedhereinabove.

One embodiment of such an adjustable stabilizing ring is depicted inFIGS. 20A-C. The adjustable stabilizing ring may include a body membercapable of assuming one or more different geometrical shapes. In somenon-limiting embodiments the body member may be composed of a memorymetal, a nickel titanium alloy, a stainless steel alloy, or acobalt-chrome alloy, alone or in combination. Such materials may havephysical and/or mechanical properties that may permit the body member toassume the one or more geometrical shapes. In some embodiments, theadjustable stabilizing ring may initially be present in an elongategeometry 2010 a as depicted in FIG. 20A. Such a geometry may allow thebody member of the stabilizing ring to be inserted into the heart orvasculature by means of a narrow catheter.

In another embodiment, the body member of the adjustable stabilizingring may transition from the elongate geometry 2010 a to an annularoperable geometry 2010 b, as depicted in FIG. 20B. The annular operablegeometry 2010 b may take on any closed geometric shape including,without limitation, a circular shape, an oval shape, a D-shape, or anyother continuously enclosed smooth shape. An adjustable stabilizing ringhaving a D-shaped annular operable geometry 2010 b may have dimensionsappropriate to the size of the natural valve annulus for which it may beused. The dimensions may include an anterior-posterior diameter of about17 mm to about 23 mm, and a commissure-commissure diameter of about 28mm to about 36 mm. Non-limiting examples of an anterior-posteriordiameter may include a diameter of about 17 mm, about 18 mm, about 19mm, about 20 mm, about 21 mm, about 22 mm, about 23 mm, or rangesbetween any two of these values (including endpoints). Non-limitingexamples of a commissure-commissure diameter may include a diameter ofabout 28 mm, about 29 mm, about 30 mm, about 31 mm, about 32 mm, about33 mm, about 34 mm, about 35 mm, about 36 mm, or ranges between any twoof these values (including endpoints). In the annular operable geometry2010 b, the adjustable stabilizing ring may be rigid or semi-rigid.

The stabilizing ring in its annular operable geometry 2010 b may alsoinclude one or more anchors 2020 as depicted in FIG. 20C. Such anchors2020 may be deployed to engage the tissue of a cardiovascular valve,such as the annular region. Over time, the engaged tissue may growaround the individual anchors 2020 thereby forming a mechanical bondthat can stabilize the ring in place near the natural cardiovascularvalve.

Because the stabilizing ring may be emplaced in the heart or vasculaturethrough the use of a catheter, it may not be possible for the physicianor other health care professional to visualize the placement directly.Imaging technology may be required to determine the proper placement ofthe stabilizing ring. In some embodiments, the stabilizing ring may beradiopaque or include radiopaque material to permit its visualizationduring emplacement.

Because the stabilizing ring may be stabilized near the naturalcardiovascular valve by the anchors 2020, a replacement valve that isplaced in mechanical contact with the ring may be similarly stabilized.Such a replacement valve may be composed of an implantable valve frameto which one or more valve leaflets are attached. The implantable valveframe may be composed of any material that is biocompatible andresistant to thrombus formation. Non-limiting examples of such valveframe material may include memory metal, a nickel titanium alloy, astainless steel alloy, and a cobalt-chrome alloy. Such a replacementvalve may include the same number of valve leaflets as the natural valvethat it may replace. Thus, the replacement valve may include animplantable valve frame having one, two, or three valve leaflets incontact therewith.

Implantable valve frames may include a variety of shapes and sizes, somenon-limiting examples of which are depicted in FIGS. 21A-H. As depictedin FIG. 21A, one embodiment of an implantable valve frame may include aframe having a D-shaped cross-section 2110 a and a constricted profile2120 a (depicted in FIG. 21C). As depicted in FIG. 21B, anotherembodiment of an implantable valve frame may include a frame having acircular cross-section 2110 b and a constricted profile 2120 a (alsodepicted in FIG. 21C). As depicted in FIG. 21D, another embodiment of animplantable valve frame may include a frame having a D-shapedcross-section 2110 a and a straight profile 2120 b (also depicted inFIG. 21E) In still another embodiment, an implantable valve frame mayinclude a frame having a circular cross section (2110b as illustrated inFIG. 21B) and a straight profile (2120 b as illustrated in FIG. 21D).

In some embodiments, as depicted in FIGS. 21F and 21G, an implantablevalve frame may be formed from a first support element 2130 a, a secondsupport element 2130 b, and at least one bridging element 2120 cextending from the first support element to the second support element.The one, two, or three replacement valve leaflets, associated with theimplantable valve frame may be at least partially secured to the firstsupport element 2130 a, the second support element 2130 b, the at leastone bridging element 2120 c, or any combination thereof. In someembodiments, the at least one bridging element 2120 c may be composed ofa single continuous surface having a first end in physical contact withthe entire first support element 2130 a and a second end in physicalcontact with the entire second support element 2130 b. In someembodiments, the implantable valve frame may be composed of a firstsupport element 2130 a, a second support element 2130 b, and at leastone bridging element 2120 c, any one or more of which may be composed ofa collapsible material. In some embodiments, the implantable valve framemay be composed of a first support element 2130 a, a second supportelement 2130 b, and at least one bridging element 2120 c in which the atleast one bridging element extends radially inwards toward a centralaxis of the valve frame. It may be recognized that such a radiallyinward extent, for a valve frame having a single bridging element, mayresult in a valve frame having a constricted profile as depicted inFIGS. 21A-C. In some embodiments, the implantable valve frame may becomposed of a first support element 2130 a, a second support element2130 b, and at least one bridging element 2120 c, any one or more ofwhich may be composed of a woven material.

In another embodiment, depicted in FIG. 21G, the at least one bridgingelement may be composed of a plurality of independent or mutually linkedbridging elements 2120 d. Some embodiments may include a plurality ofbridging elements arranged in a criss-cross manner, such as may be foundin an expandable gate. In alternative embodiments, the at least onebridging element may be constructed in the manner of a vascular stent. Avalve frame having bridging elements arranged as associated linkedcomponents may be used in conjunction with a stabilizing ring havinganchors. The linked components in the system may be rigid or semi-rigiddepending on the nature of the linkage among the linked components. Itmay be recognized that implantable valve frames in general may be atleast partially collapsible, collapsible, rigid, or semi-rigid accordingto their individual designs.

FIG. 21H further depicts a pliable coating material 2170 that may beapplied to the stabilizing ring 2150. It may be appreciated that thestabilizing ring 2150, the valve frame, or both may be coated with sucha pliable coating material 2170. In some embodiments, the pliablecoating material 2170 may be composed of a polymer. In one non-limitingexample, the pliable material may be a polyester.

FIGS. 22A-C depict several non-limiting examples of implantable valveframes including replacement valves that may be incorporated therein.Thus, FIG. 22A depicts a frame having a D-shaped cross-section with aconstricted profile 2220 a incorporating a bi-leaflet valve 2230 a. FIG.22B depicts a frame having a circular cross-section with a constrictedprofile 2220 b incorporating a tri-leaflet valve 2230 b. FIG. 22Cdepicts a frame having a D-shaped cross-section with a cylindricalprofile 2220 c incorporating a bi-leaflet valve 2230 a.

It may be appreciated that alternative frames and leaflet systems may becontemplated in addition to the examples depicted herein. Thus, a framemay include a cylindrical profile, a constricted profile, a bulgingprofile, or any other profile appropriate for stabilizing one or morevalve leaflets as required for the function of the replacement valve. Aframe may also have a D-shaped cross section, a circular cross section,an oval cross section, or a cross section having any closed geometricalshape appropriate for stabilizing one or more valve leaflets as requiredfor the function of the replacement valve. The valve frames may alsosecure one, two, three, or other number of valve leaflets as requiredfor the function of the replacement valve.

Regardless of the shape of the implantable valve frame, the valve framemay be configured to be delivered by means of a catheter. Cathetersdisclosed above with respect to the implanting of an annuloplasty ring(or adjustable stabilizing ring) may also be used to deliver theimplantable valve frames. In some examples, a catheter may be used todeploy a stabilizing ring and a valve frame. Alternative examples mayinclude a catheter for deploying a valve frame that is different fromthe catheter used to deploy a stabilizing ring. It may be understoodthat the deployed implantable valve frame may be physically larger thana lumen of a catheter used for its deployment. Thus, the implantablevalve frame may be delivered by the catheter at the locus of the naturalvalve in an at least partially collapsed state. Upon deployment, theimplantable valve frame may be expanded to a functional (expanded)state. In some embodiments, the implantable valve may expand from its atleast partially collapsed state to its expanded state under the actionsof an expansion device. In one example, the expansion device may be aballoon placed adjacent to the at least partially collapsed valve frame.Such an expansion device may expand the valve frame as the balloon isinflated. In other embodiments, the implantable valve frame may beself-expanding. Such self-expanding implantable valve frames may becomposed of a memory metal, such as a nickel titanium alloy.

FIGS. 23A-D depict non-limiting examples of a combination systemincluding an implantable valve frame and an adjustable stabilizer ring.In each of FIGS. 23A-D, an adjustable stabilizing ring 2320 havingextended anchors 2330 is depicted inclosing at least some portion of avalve frame (2310 a,b). In some embodiments, the stabilizing ring 2320may be in physical contact with at least a portion of an exteriorsurface of the valve frame (2310 a,b).

As depicted in FIGS. 23A and 23B, the implantable valve frame 2310 a maybe a D-shaped frame having a constriction with which the stabilizingring 2320 is in contact. As depicted in FIG. 23B, such a combinationsystem of valve frame 2310 a and adjustable stabilizing ring 2320 mayhouse a two-leaflet valve 2340. It may be noted in FIGS. 23A and 23Bthat the valve frame 2310 a may have a geometry permitting continuousphysical contact between the portion of the valve frame exterior surfaceand the stabilizing ring 2320.

As depicted in FIGS. 23C and 23D, the implantable valve frame 2310 b maybe a cylindrical frame having a constriction with which the stabilizingring 2320 is in contact. As depicted in FIG. 23D, such a combinationsystem of valve frame 2310 b and adjustable stabilizing ring 2320 mayhouse a three-leaflet valve 2350. It may be noted in FIGS. 23C and 23Dthat the valve frame 2310 b may have a geometry in which only partialphysical contact is made between the portion of the valve frame exteriorsurface and the stabilizing ring 2320.

In addition to the configurations depicted in FIGS. 23A-D, a stabilizingring 2320 may form a continuous physical contact with a portion of avalve frame having a D-shape cross-section, a circular cross-section, anoval cross-section, or any other continuous geometrical cross-section.Alternatively, a stabilizing ring 2320 may form only a partial physicalcontact with a portion of a valve frame having a D-shape cross-section,a circular cross-section, an oval cross-section, or any other continuousgeometrical cross-section. Further, a stabilizing ring 2320 may form acontinuous physical contact or a partial physical contact with anexterior surface of a valve frame having a constricted profile, astraight profile, or a bulging profile. It may further be understoodthat a stabilizing ring 2320 may form a continuous physical contact or apartial physical contact with any portion of an exterior surface of avalve frame regardless of the valve frame profile.

It may be understood that other combination systems of valve frames andstabilizing rings may be contemplated. Thus, an implantable valve framemay be composed of a plurality of individual segments affixed to eachother to form a criss-cross geometry or more complex geometry made fromstraight or curved links. Alternative implantable valve frames mayinclude interlaced segments In alternative non-limiting embodiments, acombination system may include multiple stabilizing rings. In onenon-limiting example, a first stabilizing ring may be in mechanicalcommunication with a proximal end of an implantable valve frame, and asecond stabilizing ring may be in mechanical communication with a distalend of an implantable valve frame.

In other examples, the implantable valve frame may incorporate featuresto assist in stabilizing its physical contact with the adjustablestabilizing ring. Such a valve frame is depicted in FIGS. 24A and 24B.As depicted in FIG. 24A, the implantable valve frame 2410 may include atleast one frame anchor 2420 in mechanical communication with an exteriorside or bridging element of the valve frame. As depicted in FIG. 24B,the adjustable stabilizing ring 2430 may be disposed in such a manner asto contact the one or more frame anchors 2420. It should be understoodthat the frame anchors 2420 may be distinguished from the anchors 2440incorporated into the stabilizing ring that may be used to anchor thestabilizing ring in the annular tissue around the natural valve.

Although FIGS. 24A and 24B depict a valve frame having a D-shapedcross-section and a constricted profile, it may be understood that anysuitable valve frame may incorporate frame anchors 2420 to assist in themechanical communication of an exterior surface of the valve frame andthe adjustable stabilizing ring. Non-limiting examples of such valveframes may be characterized by a straight profile, a constrictedprofile, a bulging profile, a circular cross-section, a D-shapedcross-section, an oval cross-section, any continuous geometricalcross-section, one or more interleaved bridging segments, a continuousbridging segment, a plurality of bridging segments, and other shapes,sizes, constructions, and geometries as known in the art.

FIG. 25 is a flow chart of an exemplary method of stabilizing areplacement of a cardiovascular valve. The distal end of a cathetercontaining at least the stabilizing ring in an elongate geometry and adelivery system thereof may be inserted 2510 into a damaged or otherwisenon-functioning natural valve. The delivery system may be used to guide2520 the ring in the elongate geometry from a proximal end of thecatheter to the distal end of the catheter. The adjustable stabilizingring may transition 2540 to an annular operable geometry upon exitingthe distal end of the catheter proximate to the valve annulus. Once thestabilizing ring is in its operable geometry, the anchors of the ringmay be deployed 2550.

It may be understood that the deployment of the stabilizing ring,including the anchors, may be sufficient to treat a malformedcardiovascular valve in the manner of an annuloplasty as disclosedabove. Over time, a health care professional may determine thatreplacement of the natural valve may be required. Subsequent proceduresmay then be used to provide a replacement valve at the site of theprevious annuloplasty. A catheter may be used to guide 2560 theimplantable valve frame through the natural cardiovascular valve andthrough the center of the pre-implanted adjustable stabilizing ring. Thevalve frame may be engaged 2570 with the stabilizing ring, therebystabilizing the position of the implantable valve frame with respect tothe natural cardiovascular valve. In some embodiments of the methodshown in FIG. 25 , the stabilizing ring and the valve frame may beintroduced into the cardiovascular system during the same surgicalprocedure. In alternative embodiments, some period of time may lapsebetween the placement of the stabilizing ring and the placement of thevalve frame. For example, the stabilizing ring may be implantedinitially to stabilize a natural cardiovascular valve, but a replacementvalve may be introduced if the patient shows signs that the stabilizingring alone is insufficient to treat the valve pathology. Alternatively,the stabilizing ring may be introduced initially and the patient’svascular system may be permitted a period of time to incorporate thestabilizing ring into the tissue before the replacement valve isintroduced. In this manner, the patient’s vascular tissue may grow intoor around the stabilizing ring to anchor or form a seal around the ringbefore the replacement valve is implanted.

In some embodiments, the implantable valve frame may be engaged with thestabilizing ring by allowing or causing the implantable valve frame toexpand to a functional size, thereby forming a mechanical contactbetween the implantable valve frame and the adjustable stabilizing ring.In some non-limiting examples, the valve frame may be allowed toself-expand. Such self-expanding valve frames may be composed of amemory material that may expand to a pre-set shape. In some alternativenon-limiting examples, the valve frame may expand under the influence ofan expansion device. Such an expansion device may be incorporated in thesame catheter as that which delivers and emplaces the implantable valveframe. In other examples, the expansion device may be deployed from acatheter that differs from the one used to emplace the valve frame. Inone non-limiting example, the expansion device may be a balloon-typedevice or a balloon.

FIG. 26 is a flow chart of an exemplary method of replacing acardiovascular valve. The distal end of a catheter containing at leastan implantable valve frame having the replacement of the cardiovascularvalve and a delivery system thereof may be inserted 2610 into a damagedor otherwise non-functioning natural cardiovascular valve. The deliverysystem may be used to guide 2620 the valve frame through the catheterand through the cardiovascular valve. The valve frame may be expanded2630, thereby deploying the replacement cardiovascular valve.

A delivery system may be used to guide 2640 a stabilizing ring in anelongate geometry through a catheter. It may be understood that the samecatheter may be used to deploy and guide the stabilizing ring and theimplantable valve frame. Alternatively, separate catheters may be usedto deliver the implantable valve frame and the stabilizing ring. Thedistal end of the catheter may be positioned through the implantablevalve frame and the replacement of the cardiovascular valve. In thismanner, the stabilizing ring, in the elongate geometry may be advanced2650 out of the catheter at a position distal to the replacement of thecardiovascular valve. The adjustable stabilizing ring may be allowed2660 to transition to an annular operable geometry around an exteriorsurface of the implantable valve frame upon exiting the distal end ofthe catheter proximate to the valve annulus. The stabilizing ring in theannular operable geometry may be engaged 2670 to the valve frame. Oncethe stabilizing ring is in its operable geometry, the anchors of thering may be deployed 2680.

In the above detailed description, reference is made to the accompanyingdrawings, which form a part hereof. In the drawings, similar symbolstypically identify similar components, unless context dictatesotherwise. The illustrative embodiments described in the detaileddescription, drawings, and claims are not meant to be limiting. Otherembodiments may be used, and other changes may be made, withoutdeparting from the spirit or scope of the subject matter presentedherein. It will be readily understood that the aspects of the presentdisclosure, as generally described herein, and illustrated in theFigures, can be arranged, substituted, combined, separated, and designedin a wide variety of different configurations, all of which areexplicitly contemplated herein.

The present disclosure is not to be limited in terms of the particularembodiments described in this application, which are intended asillustrations of various aspects. Many modifications and variations canbe made without departing from its spirit and scope, as will be apparentto those skilled in the art. Functionally equivalent methods andapparatuses within the scope of the disclosure, in addition to thoseenumerated herein, will be apparent to those skilled in the art from theforegoing descriptions. Such modifications and variations are intendedto fall within the scope of the appended claims. The present disclosureis to be limited only by the terms of the appended claims, along withthe full scope of equivalents to which such claims are entitled. It isto be understood that this disclosure is not limited to particularmethods, reagents, compounds, compositions or biological systems, whichcan, of course, vary. It is also to be understood that the terminologyused herein is for the purpose of describing particular embodimentsonly, and is not intended to be limiting.

With respect to the use of substantially any plural and/or singularterms herein, those having skill in the art can translate from theplural to the singular and/or from the singular to the plural as isappropriate to the context and/or application. The varioussingular/plural permutations may be expressly set forth herein for sakeof clarity.

It will be understood by those within the art that, in general, termsused herein, and especially in the appended claims (for example, bodiesof the appended claims) are generally intended as “open” terms (forexample, the term “including” should be interpreted as “including butnot limited to,” the term “having” should be interpreted as “having atleast,” the term “includes” should be interpreted as “includes but isnot limited to,” et cetera). While various compositions, methods, anddevices are described in terms of “comprising” various components orsteps (interpreted as meaning “including, but not limited to”), thecompositions, methods, and devices can also “consist essentially of” or“consist of” the various components and steps, and such terminologyshould be interpreted as defining essentially closed-member groups. Itwill be further understood by those within the art that if a specificnumber of an introduced claim recitation is intended, such an intentwill be explicitly recited in the claim, and in the absence of suchrecitation no such intent is present. For example, as an aid tounderstanding, the following appended claims may contain usage of theintroductory phrases “at least one” and “one or more” to introduce claimrecitations. However, the use of such phrases should not be construed toimply that the introduction of a claim recitation by the indefinitearticles “a” or “an” limits any particular claim containing suchintroduced claim recitation to embodiments containing only one suchrecitation, even when the same claim includes the introductory phrases“one or more” or “at least one” and indefinite articles such as “a” or“an” (for example, “a” and/or “an” should be interpreted to mean “atleast one” or “one or more”); the same holds true for the use ofdefinite articles used to introduce claim recitations. In addition, evenif a specific number of an introduced claim recitation is explicitlyrecited, those skilled in the art will recognize that such recitationshould be interpreted to mean at least the recited number (for example,the bare recitation of “two recitations,” without other modifiers, meansat least two recitations, or two or more recitations). Furthermore, inthose instances where a convention analogous to “at least one of A, B,and C, et cetera” is used, in general such a construction is intended inthe sense one having skill in the art would understand the convention(for example, “ a system having at least one of A, B, and C″ wouldinclude but not be limited to systems that have A alone, B alone, Calone, A and B together, A and C together, B and C together, and/or A,B, and C together, et cetera). In those instances where a conventionanalogous to “at least one of A, B, or C, et cetera” is used, in generalsuch a construction is intended in the sense one having skill in the artwould understand the convention (for example, ” a system having at leastone of A, B, or C″ would include but not be limited to systems that haveA alone, B alone, C alone, A and B together, A and C together, B and Ctogether, and/or A, B, and C together, et cetera). It will be furtherunderstood by those within the art that virtually any disjunctive wordand/or phrase presenting two or more alternative terms, whether in thedescription, claims, or drawings, should be understood to contemplatethe possibilities of including one of the terms, either of the terms, orboth terms. For example, the phrase “A or B” will be understood toinclude the possibilities of “A” or “B” or “A and B.”

In addition, where features or aspects of the disclosure are describedin terms of Markush groups, those skilled in the art will recognize thatthe disclosure is also thereby described in terms of any individualmember or subgroup of members of the Markush group.

As will be understood by one skilled in the art, for any and allpurposes, such as in terms of providing a written description, allranges disclosed herein also encompass any and all possible subrangesand combinations of subranges thereof. Any listed range can be easilyrecognized as sufficiently describing and enabling the same range beingbroken down into at least equal halves, thirds, quarters, fifths,tenths, et cetera As a non-limiting example, each range discussed hereincan be readily broken down into a lower third, middle third and upperthird, et cetera As will also be understood by one skilled in the artall language such as “up to,” “at least,” and the like include thenumber recited and refer to ranges which can be subsequently broken downinto subranges as discussed above. Finally, as will be understood by oneskilled in the art, a range includes each individual member. Thus, forexample, a group having 1-3 cells refers to groups having 1, 2, or 3cells. Similarly, a group having 1-5 cells refers to groups having 1, 2,3, 4, or 5 cells, and so forth.

Various of the above-disclosed and other features and functions, oralternatives thereof, may be combined into many other different systemsor applications. Various presently unforeseen or unanticipatedalternatives, modifications, variations or improvements therein may besubsequently made by those skilled in the art, each of which is alsointended to be encompassed by the disclosed embodiments.

What is claimed is:
 1. An implantable valve system comprising: an adjustable stabilizing ring comprising: a body member having an elongate insertion geometry and an annular operable geometry, and a plurality of anchors, housed within the body member in both the elongate insertion geometry and the annular operable geometry, wherein the plurality of anchors have a deployment configuration in the annular operable geometry to engage an annulus of a cardiovascular valve; and an implantable valve frame comprising a plurality of valve leaflets, wherein the implantable valve frame comprises at least one frame anchor configured to couple the implantable valve frame to the adjustable stabilizing ring in the annular operable geometry.
 2. The implantable valve system of claim 1, wherein the adjustable stabilizing ring, the implantable valve frame, or both are coated with a pliable material comprising a polymer.
 3. The implantable valve system of claim 1, wherein the at least implantable valve frame extends radially inward towards a central axis of the implantable valve frame.
 4. The implantable valve system of claim 1, wherein the implantable valve frame comprises a first support element, a second support element, and at least one bridging element extending from the first support element to the second support element.
 5. The implantable valve system of claim 4, wherein first support element extends radially inward at a first angle toward the at least one bridging element and the second support element extends radially inward at a second angle toward the at least one bridging element.
 6. The implantable valve system of claim 5, wherein the first angle is different than the second angle.
 7. The implantable valve system of claim 4, wherein the plurality of leaflets are at least partially secured to the first support element, the second support element, the at least one bridging element, or any combination thereof.
 8. The implantable valve system of claim 4, wherein the at least one bridging element comprises a continuous surface having a first end and a second end, wherein the first end is in physical contact with an entirety of the first support element and the second end is in physical contact with an entirety of the second support element.
 9. The implantable valve system of claim 4, wherein the at least one bridging element comprises a collapsible material.
 10. The implantable valve system of claim 4, wherein the at least one bridging element extends radially inwards towards a central axis of the implantable valve frame.
 11. The implantable valve system of claim 4, wherein at least a portion of an exterior surface of the at least one bridging element is in mechanical communication with the adjustable stabilizing ring.
 12. The implantable valve system of claim 1, wherein the implantable valve frame is at least partially collapsible.
 13. The implantable valve system of claim 1, wherein the implantable valve frame is configured to be delivered via a catheter in an at least partially collapsed state.
 14. The implantable valve system of claim 13, wherein the implantable valve frame is expandable from the at least partially collapsed state.
 15. The implantable valve system of claim 1, wherein the implantable valve frame comprises one or more of a memory metal, a nickel titanium alloy, a stainless steel alloy, and a cobalt-chrome alloy.
 16. The implantable valve system of claim 1, wherein the implantable valve frame comprise a substantially D-shape.
 17. The implantable valve system of claim 1, wherein the at least one frame anchor is configured to partially encompass the adjustable stabilizing ring.
 18. The implantable valve system of claim 1, wherein the at least one frame anchor comprises a C-shape.
 19. The implantable valve system of claim 1, wherein the annular operable geometry has a closed state to conform to the annulus of the cardiovascular valve.
 20. The implantable valve system of claim 1, wherein the adjustable stabilizing ring has at least one gap between the implantable valve frame and the adjustable stabilizing ring. 